Intramedullary fracture fixation devices and methods

ABSTRACT

An intramedullary bone fixation device is provided with an elongate body having a longitudinal axis and an actuator to deploy at least one gripper to engage an inner surface of the intramedullary space to anchor the fixation device to the bone. Methods of repairing a fracture of a bone are also disclosed. One such method comprises inserting a fixation device into an intramedullary space of the bone to place at least a portion of the fixation device on one side of the fracture, providing rigidity across the fracture, and operating an actuator to deploy at least one gripper to engage an inner surface of the intramedullary space to anchor the fixation device to the bone. Various configurations allow a segmented device body to lock in the intramedullary space before and/or after fixation of the bone.

INCORPORATION BY REFERENCE

The present application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 62/057,913 filed on Sep. 30, 2014, thedisclosures of this application is incorporated by reference herein inits entirety. All publications and patent applications mentioned in thisspecification are herein incorporated by reference in their entirety tothe same extent as if each individual publication or patent applicationwas specifically and individually indicated to be incorporated byreference. For example, U.S. patent application Ser. No. 13/615,078,filed Sep. 13, 2012 is incorporated by reference in its entirety,including all applications to which it claims priority. For example,U.S. patent application Ser. No. 13/614,523, filed Sep. 13, 2012 isincorporated by reference in its entirety, including all applications towhich it claims priority.

BACKGROUND OF THE INVENTION

Field of the Invention

Embodiments of the present invention relate to devices, tools andmethods for providing reinforcement of bones. More specifically, thepresent invention relates to devices, tools and methods for providingreconstruction and reinforcement of bones, including diseased,osteoporotic and/or fractured bones.

Description of the Related Art

The number and diversity of sports and work related fractures are beingdriven by several sociological factors. The diversity of high energysports has increased and the participation in these sports has followedthe general trend of affluence and the resultant amount of time forleisure. High energy sports include skiing, motorcycle riding, snowmobile riding, snowboarding, mountain biking, road biking, kayaking, andall terrain vehicle (ATV) riding. As the general affluence of theeconomically developed countries has increased the number (or amount)and age of people participating in these activities has increased.Lastly, the acceptance and ubiquitous application of passive restraintsystems, airbags, in automobiles has created greater numbers of non-lifethreatening fractures. In the past, a person that might expire from aserious automobile accident now survives with multiple traumas andresultant fractures.

Bone fractures are a common medical condition both in the young and oldsegments of the population. However, with an increasingly agingpopulation, osteoporosis has become more of a significant medicalconcern in part due to the risk of osteoporotic fractures. Osteoporosisand osteoarthritis are among the most common conditions to affect themusculoskeletal system, as well as frequent causes of locomotor pain anddisability. Osteoporosis can occur in both human and animal subjects(e.g. horses). Osteoporosis (OP) and osteoarthritis (OA) occur in asubstantial portion of the human population over the age of fifty. TheNational Osteoporosis Foundation estimates that as many as 44 millionAmericans are affected by osteoporosis and low bone mass, leading tofractures in more than 300,000 people over the age of 65. In 1997 theestimated cost for osteoporosis related fractures was $13 billion. Thatfigure increased to $17 billion in 2002 and is projected to increase to$210-240 billion by 2040. Currently it is expected that one in twowomen, and one in four men, over the age of 50 will suffer anosteoporosis-related fracture. Osteoporosis is the most importantunderlying cause of fracture in the elderly. Also, sports andwork-related accidents account for a significant number of bonefractures seen in emergency rooms among all age groups.

One current treatment of bone fractures includes surgically resettingthe fractured bone. After the surgical procedure, the fractured area ofthe body (i.e., where the fractured bone is located) is often placed inan external cast for an extended period of time to ensure that thefractured bone heals properly. This can take several months for the boneto heal and for the patient to remove the cast before resuming normalactivities.

In some instances, an intramedullary (IM) rod or nail is used to alignand stabilize the fracture. In that instance, a metal rod is placedinside a canal of a bone and fixed in place, typically at both ends.See, for example, Fixion™ IM (Nail), www.disc-o-tech.com. Placement ofconventional IM rods are typically a “line of sight” and require accesscollinear with the center line of the IM canal. Invariably, this line ofsight access violates, disrupts, and causes damage to important softtissue structures such as ligaments, tendons, cartilage, fascia, andepidermis. This approach requires incision, access to the canal, andplacement of the IM nail. The nail can be subsequently removed or leftin place. A conventional IM nail procedure requires a similar, butpossibly larger, opening to the space, a long metallic nail being placedacross the fracture, and either subsequent removal, and or when the nailis not removed, a long term implant of the IM nail. The outer diameterof the IM nail must be selected for the minimum inside diameter of thespace. Therefore, portions of the IM nail may not be in contact with thecanal. Further, micro-motion between the bone and the IM nail may causepain or necrosis of the bone. In still other cases, infection can occur.The IM nail may be removed after the fracture has healed. This requiresa subsequent surgery with all of the complications and risks of a laterintrusive procedure. In general, rigid IM rods or nails are difficult toinsert, can damage the bone and require additional incisions forcross-screws to attach the rods or nails to the bone.

In view of the foregoing, it would be desirable to have a device, systemand method for providing effective and minimally invasive bonereinforcement and fracture fixation to treat fractured or diseasedbones, while improving the ease of insertion, eliminating cross-screwincisions and minimizing trauma.

SUMMARY

As used herein, the term “aspect” may be used interchangeably with theterm “embodiment.” Aspects of the invention relate to embodiments of abone fixation device and to methods for using such a device forrepairing a bone fracture. The bone fixation device may include anelongate body with a longitudinal axis, and/or having a flexible stateand a rigid state. The device further may include a plurality ofgrippers disposed at longitudinally-spaced locations along the elongatebody, a rigid hub connected to the elongate body, and an actuator thatis operably-connected to the grippers to deploy the grippers from afirst shape to an expanded second shape. In various embodiments, theelongate body and the rigid hub may or may not be collinear or parallel.

In one embodiment, a bone fixation device is provided with an elongatebody; an oblong aperture in the elongate body configured to accept ascrew; an bone engaging mechanism disposed within the elongate body; anactuator operably connected to the bone engaging mechanism to actuatethe bone engaging mechanism from a disengaged configuration to anengaged configuration, wherein the actuator comprises a ramped surfacethat is slideably coupled to an interior surface of the bone engagingmechanism, wherein proximally moving the ramped surface of the actuatorcauses the ramped surface to slideably engage the interior surface ofthe bone engaging mechanism at an angle thereby pivoting the boneengaging mechanism away from the elongate body to deploy the boneengaging mechanism into the engaged configuration; and wherein the screwis configured to be pushed from a first position within the oblongaperture to a second position within the oblong aperture to reduce afracture.

A screw driver configured to engage with a corresponding hex socket, thescrew driver is provided with a shaft having a proximal end and a distalend; the distal end having a hex tip comprising at least six flats and aslot bisecting at least two of the six flats; and wherein the hex tip isdeformed outward to create an interference with the corresponding hexsocket.

Methods of repairing a bone fracture are also disclosed. One such methodcomprises providing an elongate fixation device having a proximal end, adistal end, an oblong aperture, and a radially expandable gripper;extending the radially expandable gripper away from the elongatefixation device by moving a ramped surface of an actuator head towardthe proximal end thereby engaging the radially expandable gripper with asurface of an intramedullary canal of a first bone segment; inserting afirst screw into a second bone segment and through the oblong aperture;and translating the first screw to reduce a distance between the firstbone segment and the second bone segment.

A system for installing a screw is provided including a bone fixationdevice having an elongate body; an oblong aperture in the elongate bodyconfigured to accept the screw, a bone engaging mechanism, and anactuator operably coupled to the bone engaging mechanism to actuate thebone engaging mechanism from a disengaged configuration to an engagedconfiguration; and a combination tool operably connected to the elongatebody, wherein the combination tool comprises at least one boreconfigured to align with the oblong aperture in the elongate body.

Methods of repairing a bone fracture between a first bone segment and asecond bone segment of a bone are also disclosed. One such methodcomprises providing an elongate body having an oblong aperture and abone engaging mechanism; coupling the elongate body with a combinationtool having a first bore configured to accept a K-wire; extending theelongate body into a canal of the bone of the first bone segment;extending the K-wire through the first bore and into the second bonesegment; and manipulating the combination tool to reposition the firstbone segment relative to the second bone segment. One such methodcomprises extending a first K-wire into the first bone segment and asecond K-wire into the second bone segment; coupling the first K-wireand the second K-wire to a distractor; manipulating the distractor toreposition the first bone segment relative to the second bone segment;reaming a canal in the first bone segment and the second bone segment;coupling an elongate body having an oblong aperture with a combinationtool; and inserting the elongate body into the canal.

A reamer configured to be used with bone is provided with a shaft havinga proximal end and a distal end; the distal end having at least onespiral cutting edge having a first diameter; the proximal end having ahandle; and wherein a portion of the shaft has a diameter less than thefirst diameter.

A method of using a bone fixation device is provided including the stepsof providing an elongate body having a bone engaging mechanism;extending the elongate body into a canal of a bone; and actuating thebone engaging mechanism from a disengaged configuration to an engagedconfiguration, wherein in the engaged configuration, the bone engagingmechanism pivots away from the elongate body to deploy the bone engagingmechanism against the wall of the canal.

In some embodiments, a method of inserting a device is provided. Themethod can include the step of inserting a device within theintramedullary canal of a fibula, the device comprising one or moreapertures. The method can include the step of inserting a first fastenerthrough the device in a lateral-medial direction. The method can includethe step of inserting a second fastener through the device, the secondscrew angled from the first screw by angle alpha. The method can includethe step of inserting a third fastener through the device, the thirdscrew angled from the first screw by angle beta, wherein the third screwextends into the tibia. The method can include the step of actuating amechanism of the device to grip the intramedullary canal of a fibula.

In some embodiments, angle alpha is between 45-75 degrees. In someembodiments, angle beta is between 10-40 degrees. The method can includethe step of translating the first fastener within an aperture of thedevice toward the mechanism. The method can include the step of rotatingthe first fastener, wherein the rotation of the first fastener causestranslation of the first fastener within an aperture of the devicetoward the mechanism. In some embodiments, actuating the mechanismcomprises deflecting three members towards the intramedullary canal. Insome embodiments, the first fastener and the second fastener arecontained within the fibula. In some embodiments, the third fastener isa screw. The method can include the step of passing at least one of thefirst fastener, the second fastener, and the third fastener through anaperture in a tool aligned with an aperture in the device. The methodcan include the step of inserting K-wires within bones portion near afracture and rotating the bone portions using the K-wires. In someembodiments, rotating the bone portions further comprises rotating aknob of a distractor.

In some embodiments, a device is provided. The device can include anelongate body comprising at least a first aperture, a second apertureand a third aperture. In some embodiments, the elongate body sized to beinserted within the fibula. The device can include a first fastenerconfigured to be inserted through the first aperture in a lateral-medialdirection. The device can include a second fastener configured to beinserted through the second aperture. In some embodiments, the secondaperture angled from the first aperture by angle alpha. The device caninclude a third fastener configured to be inserted through the thirdaperture. In some embodiments, the third aperture angled from the firstscrew by angle beta. In some embodiments, the third fastener has alonger length than the first fastener and the second fastener. Thedevice can include an actuator configured to actuate a portion of thedevice to grip the intramedullary canal of a fibula.

In some embodiments, angle alpha is 60 degrees. In some embodiments,angle beta is 25 degrees. In some embodiments, the first aperture isoblong, wherein the first fastener is configured to translate within thefirst aperture toward the actuator. In some embodiments, the portioncomprises three members configured to deflect towards the intramedullarycanal. In some embodiments, the first fastener and the second fastenerare sized to be contained within the fibula. In some embodiments, thethird fastener is sized to extend into the tibia. In some embodiments,the third fastener is a screw. The device can include a tool comprisingat least a fourth aperture aligned with the first aperture, a fifthaperture aligned with the second aperture and a sixth aperture alignedwith the third aperture.

These and other features and advantages of the present invention will beunderstood upon consideration of the following detailed description ofthe invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a perspective view of an embodiment of a bone fixation deviceimplanted in a bone.

FIG. 2 is another perspective view of the implanted device of FIG. 1.

FIG. 3 is a longitudinal cross-section view of the bone fixation deviceof FIG. 1 in a non-deployed state.

FIG. 4 is a plan view of a combination deployment tool that may be usedwith the bone fixation device of FIG. 1.

FIG. 5 is a cross-section view of the tool and device shown in FIG. 4.

FIG. 6 is a perspective view of the tool and device shown in FIG. 4.

FIG. 7A is a cross-section view of the implanted device of FIG. 1.

FIG. 7B is a plan view of an alternative combination deployment toolthat may be used with the bone fixation device of FIG. 1.

FIG. 8 is a perspective view of an alternative embodiment of theimplanted device of FIG. 1.

FIG. 9 is a perspective view of another alternative embodiment of theimplanted device of FIG. 1.

FIG. 10A is a perspective view of another embodiment of a bone fixationdevice shown deployed in a fractured clavicle.

FIG. 10B is perspective view of the device shown in FIG. 10A shown in adeployed state.

FIG. 10C is a side elevation view of the device shown in FIG. 10A shownin a retracted or undeployed state.

FIG. 10D is a side elevation view of the device shown in FIG. 10A shownin a deployed state.

FIG. 10E is a cross-sectional view of the device shown in FIG. 10A shownin a retracted or undeployed state.

FIG. 10F is a cross-sectional view of the device shown in FIG. 10A shownin a deployed state.

FIG. 10G is a perspective view of a gripper of the device shown in FIG.10A shown in a retracted or undeployed state.

FIG. 10H is a side elevation view of a gripper and actuator of thedevice shown in FIG. 10A shown in a retracted or undeployed state.

FIG. 10I is a perspective view of a gripper and actuator of the deviceshown in FIG. 10A shown in a deployed state.

FIG. 11 is perspective view of another embodiment of a bone fixationdevice shown in a retracted or undeployed state.

FIG. 12 is perspective view of the device shown in FIG. 11 shown in adeployed state.

FIG. 13 is perspective view of the distal end of the device shown inFIG. 12 shown in a deployed state.

FIG. 14 is a cross-sectional view of the device shown in FIG. 12 shownin a deployed state.

FIG. 15 is a cross-sectional view of the distal end of the device shownin FIG. 12 shown in a deployed state.

FIG. 16A is perspective view of the device shown in FIG. 12 shown in adeployed state prior to insertion of a screw.

FIG. 16B is perspective view of the device shown in FIG. 16A shown in adeployed state during insertion of the screw.

FIG. 16C is perspective view of the device shown in FIG. 16A shown in adeployed state after translation of the screw.

FIG. 17 is a cross-sectional view of the device shown in FIG. 16C shownin a deployed state after translation of the screw.

FIG. 18 is a cross-sectional view of the device shown in FIG. 16C shownin a deployed state after insertion of a cap.

FIG. 19 is a cross-sectional view of the proximal end of the deviceshown in FIG. 18 shown in a deployed state after insertion of a cap.

FIG. 20 is a perspective view of the another embodiment of a bonefixation device shown in a deployed state

FIG. 21 is a perspective view of an embodiment of a tool.

FIG. 22 is a perspective view the tool shown in FIG. 21 coupled to thebone fixation device of FIG. 12

FIG. 23 is a perspective view of the system shown in FIG. 22 shown in adeployed state during insertion of the screw.

FIG. 24 is cross-sectional view of the system shown in FIG. 22 shown ina deployed state during insertion of the screw.

FIG. 25 is cross-sectional view of the system shown in FIG. 22 shown ina deployed state after translation of the screw.

FIG. 26 is cross-sectional view of the proximal end of the system shownin FIG. 22 shown in a deployed state after translation of the screw.

FIG. 27 is cross-sectional view of the proximal end of the system shownin FIG. 22 shown in a deployed state after insertion of a cap.

FIG. 28A is a perspective view of the device shown in FIG. 16A duringinsertion of the screw.

FIG. 28B is a perspective view of the device shown in FIG. 16A shown ina deployed state after translation of the screw.

FIG. 29 is a perspective view of an embodiment of a screw driver.

FIG. 30 is a perspective view of the distal end of the screw driver ofFIG. 29.

FIGS. 31A-31I are various views of entry points of the tibia to implantthe device of FIGS. 1-30.

FIGS. 32A-32J are various method steps to implant the device of FIGS.1-30.

FIGS. 33A-33G are various steps of methods to implant the device ofFIGS. 1-30.

FIGS. 34A-34D are various steps of methods to implant the device ofFIGS. 1-30.

FIGS. 35A-35B are perspective views of another embodiment of a bonefixation device shown in a deployed state.

FIG. 36 is a perspective view of the distal end of the device shown inFIG. 35A in a deployed state.

FIG. 37 is a longitudinal cross-section view of the bone fixation deviceof FIG. 35A in a deployed state

FIGS. 38A-38D are schematic views of the device shown in FIG. 35A.

FIGS. 39A-39B are perspective views of the proximal end of the deviceshown in FIG. 35A.

FIG. 40 is a perspective view of the device shown in FIG. 35A duringinsertion of a compression screw.

FIGS. 41A-41B are perspective views of the device shown in FIG. 35Ashown in a deployed state during syndesmosis fixation.

FIG. 42 is a view of the anatomy.

FIGS. 43A-43C are views of the anatomy.

FIGS. 44A-44S are various method steps to implant the device of FIGS.35-41B.

FIGS. 45A-45O are various tools to implant the device of FIGS. 35-41B.

DETAILED DESCRIPTION

By way of background and to provide context for the invention, it may beuseful to understand that bone is often described as a specializedconnective tissue that serves three major functions anatomically. First,bone provides a mechanical function by providing structure and muscularattachment for movement. Second, bone provides a metabolic function byproviding a reserve for calcium and phosphate. Finally, bone provides aprotective function by enclosing bone marrow and vital organs. Bones canbe categorized as long bones (e.g. radius, femur, tibia and humerus) andflat bones (e.g. skull, scapula and mandible). Each bone type has adifferent embryological template. Further each bone type containscortical and trabecular bone in varying proportions. The devices of thisinvention can be adapted for use in any of the bones of the body as willbe appreciated by those skilled in the art.

Cortical bone (compact) forms the shaft, or diaphysis, of long bones andthe outer shell of flat bones. The cortical bone provides the mainmechanical and protective function. The trabecular bone (cancellous) isfound at the end of the long bones, or the epiphysis, and inside thecortex of flat bones. The trabecular bone consists of a network ofinterconnecting trabecular plates and rods and is the major site of boneremodeling and resorption for mineral homeostasis. During development,the zone of growth between the epiphysis and diaphysis is themetaphysis. Finally, woven bone, which lacks the organized structure ofcortical or cancellous bone, is the first bone laid down during fracturerepair. Once a bone is fractured, the bone segments are positioned inproximity to each other in a manner that enables woven bone to be laiddown on the surface of the fracture. This description of anatomy andphysiology is provided in order to facilitate an understanding of theinvention. Persons of skill in the art will also appreciate that thescope and nature of the invention is not limited by the anatomydiscussion provided. Further, it will be appreciated there can bevariations in anatomical characteristics of an individual patient, as aresult of a variety of factors, which are not described herein. Further,it will be appreciated there can be variations in anatomicalcharacteristics between bones which are not described herein.

FIGS. 1 and 2 are perspective views of an embodiment of a bone fixationdevice 3100 having a proximal end 3102 (nearest the surgeon) and adistal end 3104 (further from surgeon) and positioned within the bonespace of a patient according to the invention. In this example, device3100 is shown implanted in the upper (or proximal) end of an ulna 3106.The proximal end and distal end, as used in this context, refers to theposition of an end of the device relative to the remainder of the deviceor the opposing end as it appears in the drawing. The proximal end canbe used to refer to the end manipulated by the user or physician. Thedistal end can be used to refer to the end of the device that isinserted and advanced within the bone and is furthest away from thephysician. As will be appreciated by those skilled in the art, the useof proximal and distal could change in another context, e.g. theanatomical context in which proximal and distal use the patient asreference, or where the entry point is distal from the surgeon.

When implanted within a patient, the device can be held in place withsuitable fasteners such as wire, screws, nails, bolts, nuts and/orwashers. The device 3100 is used for fixation of fractures of theproximal or distal end of long bones such as intracapsular,intertrochanteric, intercervical, supracondular, or condular fracturesof the femur; for fusion of a joint; or for surgical procedures thatinvolve cutting a bone. The devices 3100 may be implanted or attachedthrough the skin so that a pulling force (traction may be applied to theskeletal system).

In the embodiment shown in FIG. 1, the design of the metaphysealfixation device 3100 depicted is adapted to provide a bone engagingmechanism or gripper 3108 adapted to engage target bone of a patientfrom the inside of the bone. As configured for this anatomicalapplication, the device is designed to facilitate bone healing whenplaced in the intramedullary space within a post fractured bone. Thisdevice 3100 has a gripper 3108 positioned distally and shown deployedradially outward against the wall of the intramedullary cavity. On entryinto the cavity, gripper 3108 is flat and retracted (FIG. 3). Upondeployment, gripper 3108 pivots radially outward and grips thediaphyseal bone from the inside of the bone. One or more screws 3110placed through apertures through the hub 3112 lock the device 3100 tothe metaphyseal bone. Hence, the metaphysis and the diaphysis arejoined. A flexible-to-rigid body portion 3114 may also be provided, andin this embodiment is positioned between gripper 3108 and hub 3112. Itmay be provided with wavy spiral cuts 3116 for that purpose, as will bedescribed in more detail below.

FIG. 3 shows a longitudinal cross-section of device 3100 in anon-deployed configuration. In this embodiment, gripper 3108 includestwo pairs of opposing bendable gripping members 3118. Two of thebendable gripping members 3118 are shown in FIG. 3, while the other two(not shown in FIG. 3) are located at the same axial location but offsetby 90 degrees. Each bendable gripping member 3118 has a thinned portion3120 that permits bending as the opposite distal end 3122 of member 3118is urged radially outward, such that member 3118 pivots about thinnedportion 3120. When extended, distal ends 3122 of bendable members 3118contact the inside of the bone to anchor the distal portion of device3100 to the bone. In alternative embodiments (not shown), the grippermay comprise 1, 2, 3, 4, 5, 6 or more bendable members similar tomembers 3118 shown.

During actuation, bendable members 3118 of gripper 3108 are urgedradially outward by a ramped surface on actuator head 3124. Actuatorhead 3124 is formed on the distal end of actuator 3126. The proximal endof actuator 3126 is threaded to engage a threaded bore of drive member3128. The proximal end of drive member 3128 is provided with a keyedsocket 3130 for receiving the tip of a rotary driver tool 3132 (shown inFIG. 5) through the proximal bore of device 3100. As rotary driver tool3132 turns drive member 3128, actuator 3126 is drawn in a proximaldirection to outwardly actuate gripper members 3118.

A hemispherical tip cover 3134 may be provided at the distal end of thedevice as shown to act as a blunt obturator. This arrangementfacilitates penetration of bone (e.g. an intramedullary space) by device3100 while keeping the tip of device 3100 from digging into bone duringinsertion.

As previously mentioned, device 3100 may include one or moreflexible-to-rigid body portions 3114. This feature is flexible uponentry into bone and rigid upon application of compressive axial forceprovided by tensioning actuator 3126. Various embodiments of aflexible-to-rigid portion may be used, including dual helical springswhose inner and outer tubular components coil in opposite directions, achain of ball bearings with flats or roughened surfaces, a chain ofcylinders with flats, features, cones, spherical or pointedinterdigitating surfaces, wavy-helical cut tubes, two helical cut tubesin opposite directions, linear wires with interdigitating coils, andbellows-like structures.

The design of the flexible-to-rigid tubular body portion 3114 allows asingle-piece design to maximize the transformation of the same body froma very flexible member that minimizes strength in bending to a rigidbody that maximizes strength in bending and torsion. The flexible membertransforms to a rigid member when compressive forces are applied in theaxial direction at each end, such as by an actuator similar to 3126. Thebody portion 3114 is made, for example, by a near-helical cut 3116 on atubular member at an angle of incidence to the axis somewhere between 0and 180 degrees from the longitudinal axis of the tubular body portion3114. The near-helical cut or wavy-helical cut may be formed by thesuperposition of a helical curve added to a cyclic curve that produceswaves of frequencies equal or greater than zero per turn around thecircumference and with cyclic amplitude greater than zero. The waves ofone segment nest with those on either side of it, thus increasing thetorque, bending strength and stiffness of the tubular body whensubjective to compressive forces. The tapered surfaces formed by theincident angle allow each turn to overlap or interdigitate with thesegment on either side of it, thus increasing the bending strength whenthe body is in compression. Additionally, the cuts can be altered indepth and distance between the cuts on the longitudinal axis along thelength of body portion 3114 to variably alter the flexible-to-rigidcharacteristics of the tubular body along its length.

The cuts 3116 in body portion 3114 allow an otherwise rigid member toincrease its flexibility to a large degree during deployment. Thetubular member can have constant or varying internal and externaldiameters. This design reduces the number of parts of theflexible-to-rigid body portion of the device and allows insertion andextraction of the device through a curved entry port in the bone whilemaximizing its rigidity once inserted. Application and removal ofcompressive forces provided by a parallel member such as wire(s),tension ribbons, a sheath, wound flexible cable, or actuator 3126 asshown will transform the body from flexible to rigid and vice versa.

In operation, as actuator 3126 is tightened, gripper members 3118 areextended radially outwardly. Once the distal ends of gripper members3118 contact bone and stop moving outward, continued rotation ofactuator 3126 draws the proximal end 3102 and the distal end 3104 ofdevice 3100 closer together until cuts 3116 are substantially closed. Inone embodiment, as this happens, body portion 3114 changes from beingflexible to rigid to better secure the bone fracture. Rotating drivemember 3128 in the opposite direction causes body portion 3114 to changefrom a rigid to a flexible state, such as for removing device 3100 ifneeded in the initial procedure or during a subsequent procedure afterthe bone fracture(s) have partially or completely healed. Body portion3114 may be provided with a solid longitudinal portion 3136 (as seen inFIGS. 3 and 9) such that cuts 3116 are a series of individual cuts eachtraversing less than 360 degrees in circumference, rather than a single,continuous helical cut. This solid portion 3136 can aid in removal ofdevice 3100 by keeping body portion 3114 from extending axially like aspring.

FIG. 4 illustrates a combination tool 3138 useful for inserting device3100, actuating gripper 3108, compressing flexible-to-rigid body portion3114, approximating the fracture in bone 3106, aligning anchor screw(s)3110, and removing device 3100, if desired. In this exemplaryembodiment, tool 3138 includes an L-shaped body 3140 that mounts theother components of the tool and also serves as a handle. The maincomponents of tool 3138 are a device attachment portion 3142, a rotarydriver 3132, an approximating driver 3144, and a screw alignment portion3146.

FIG. 5 shows a cross-section of the tool 3138 and device 3100illustrated in FIG. 4. As shown, device attachment portion 3142 includesa knob 3148 rigidly coupled to a tube 3150 which is rotatably mountedwithin sleeve 3152. Sleeve 3152 in turn is fixedly mounted to tool body3140. The distal end of tube 3150 is provided with external threads forengaging the internal threads on the proximal end of device 3100. Asseen in FIG. 4, both the distal end of sleeve 3152 and the proximal endof device 3100 may be provided with semicircular steps that inter-engageto prevent device 3100 from rotating with respect to sleeve 3152. Withthis arrangement, device 3100 can be prevented from rotating when it issecured to tool 3138 by tube 3150 of device attachment portion 3142. Themating semicircular steps also serve to position device 3100 in aparticular axial and angular orientation with respect to tool 3138 foraligning screws with screw holes, as will be later described.

Rotary driver 3132 may be used to actuate gripper 3108 and compressflexible-to-rigid body portion 3114 after device 3100 is inserted intobone 3106. Driver 3132 may also be used to allow body portion 3114 todecompress and gripper 3108 to retract if removal of device 3100 frombone 3106 is desired. In the embodiment shown, driver 3132 includes knob3154, torsion spring 3156, hub 3158, bushing 3160 and shaft 3162. Thedistal end of shaft 3162 is provided with a mating tip 3164, such as onehaving a hex-key shape, for engaging with keyed socket 3130 of device3100 (seen in FIG. 3), such that turning driver shaft 3162 turns drivemember 3128 and axially actuates actuator 3126, as described above.

The proximal end of shaft 3162 may be fitted with a bushing 3160, suchas with a press-fit. Hub 3158 may be secured over bushing 3160, such aswith a pin through bushing 3160 and shaft 3162. In this embodiment, knob3154 is rotatably mounted over hub 3158 and bushing 3160 such that knob3154 can rotate independently from shaft 3162. A torsion spring 3156 maybe used to couple knob 3154 to hub 3158 as shown to create a torquelimiting and/or torque measuring driver. With this indirect couplingarrangement, as knob 3154 is rotated about shaft 3162, spring 3156 urgeshub 3158 and shaft 3162 to rotate in the same direction. Rotationalresistance applied by device 3100 to shaft tip 3164 will increase inthis embodiment as gripper 3108 engages bone 3106, and flexible-to-rigidbody portion 3114 compresses. As more torque is applied to knob 3154, itwill advance rotationally with respect to hub 3158 as torsion spring3156 undergoes more stress. Markings may be provided on knob 3154 andhub 3158 to indicate the torque being applied. In this manner, a surgeoncan use driver 3132 to apply torque to device 3100 in a predeterminedrange. This can help ensure that gripper 3108 is adequately set in bone3106, body portion 3114 is sufficiently compressed, and excessive torqueis not being applied that might damage device 3100, bone 3106 or causeslippage therebetween. A slip clutch or other mechanism may be providedto allow the applied torque to be limited or indicated. For example,driver 3132 may be configured to “click” into or out of a detentposition when a desired torque is reached, thus allowing the surgeon toapply a desired torque without needing to observe any indicia on thedriver. In alternative embodiments, the driver knob may be selectably orpermanently coupled to shaft 3162 directly.

After device 3100 is inserted in bone 3106 and deployed with tool 3138as described above, the approximating driver portion 3144 of tool 3138may be used to compress one or more fractures in bone 3106.Approximating driver 3144 includes knob 3166 located on sleeve 3152.Knob 3166 may be knurled on an outer circumference, and have threads onat least a portion of its axial bore. The internal threads of knob 3166engage with mating external threads on sleeve 3152 such that when knob3166 is rotated it advances axially with respect to sleeve 3152. Whendevice 3100 is anchored in bone 3106, sleeve 3152 is prevented frommoving away from the bone. Accordingly, as knob 3166 is advanced axiallytoward bone 3106, it serves to approximate bone fractures locatedbetween gripper 3108 and knob 3166. Suitable thread pitch and knobcircumference may be selected to allow a surgeon to supply a desiredapproximating force to bone 3106 by using a reasonable rotation force onknob 3166. In alternative embodiments (not shown), a torque indicatingand/or torque limiting mechanism as described above may be incorporatedinto approximating driver 3144.

As previously indicated, tool 3138 may also include a screw alignmentportion 3146. In the embodiment depicted in the figures, alignmentportion 3146 includes a removable alignment tube 3168 and two bores 3170and 3172 through tool body 3140. In alternative embodiments (not shown),a single bore or more than two bores may be used, with or without theuse of separate alignment tube(s).

In operation, alignment tube 3168 is first received in bore 3170 asshown. In this position, tube 3168 is in axial alignment with angledhole 3174 at the distal end 3102 of device 3100. As described above, themating semicircular steps of device 3100 and sleeve 3152 position angledhole 3174 in its desired orientation. With this arrangement, a drillbit, screw driver, screw and/or other fastening device or tool may beinserted through the bore of tube 3168 such that the device(s) areproperly aligned with hole 3174. The outward end of alignment tube 3168may also serve as a depth guide to stop a drill bit, screw and/or otherfastener from penetrating bone 3106 beyond a predetermined depth.

Alignment tube 3168 may be withdrawn from bore 3170 as shown, andinserted in bore 3172. In this position, tube 3168 aligns with hole 3176of device 3100. As described above, a drill bit, screw driver, screwand/or other fastening device may be inserted through the bore of tube3168 such that the device(s) are properly aligned with hole 3176.

FIG. 6 shows alignment tube 3168 of tool 3138 aligning screw 3110 withangled hole 3174 at the distal end of device 3100, as described above.

FIG. 7A shows a first screw 3110 received through angled hole 3174 and asecond screw 3110 received through hole 3176 in device 3100 and intobone 3106. Screws 3110 may be installed manually or with the aid of tool3138 as described above. The heads of screws 3110 may be configured tobe self-countersinking such that they remain substantially beneath theouter surface of the bone when installed, as shown, so as to notinterfere with adjacent tissue. In this embodiment, the proximal end3102 of device 3100 is secured to bone 3106 with two screws 3110, andthe distal end 3104 is secured by gripper 3108. In this manner, any bonefractures located between the proximal screw 3110 and distal gripper3108 may be approximated and rigidly held together by device 3100. Inalternative embodiments (not shown), more than one gripper may be used,or only screws or other fasteners without grippers may be used to securedevice 3100 within bone 3106. For example, the device shown in FIG. 1could be configured with a second gripper located between screw 3110 andthe middle of the device if the fracture is located more at themid-shaft of the bone. Similarly, more than two screws or otherfasteners may be used, or only grippers without fasteners may be used.In various embodiments, holes such as 3174 and 3176 as shown anddescribed above can be preformed in the implantable device. In otherembodiments, some or all of the holes can be drilled or otherwise formedin situ after the device is implanted in the bone.

Once device 3100 is secured within bone 3106, combination tool 3138 maybe removed by turning knob 3148 to disengage threads of tube 3150 fromthreads within the proximal end 3102 of device 3100. An end plug 3178may be threaded into the proximal end 3102 of device 3100 to preventinggrowth of tissue into implanted device 3100. Device 3100 may be left inbone 3106 permanently, or it may be removed by performing the abovedescribed steps in reverse. In particular, plug 3178 is removed, tool3138 is attached, screws 3110 are removed, gripper 3108 is retracted,and device 3100 is pulled out using tool 3138.

FIG. 7B shows an alternative embodiment of a combination tool 3138′useful for inserting device 3100, actuating gripper 3108, compressingflexible-to-rigid body portion 3114, approximating the fracture in bone3106, aligning anchor screw(s) 3110, and removing device 3100, ifdesired. Like tool 3138 described above, exemplary tool 3138′ includesan L-shaped body 3140′ that mounts the other components of the tool andalso serves as a handle. The main components of tool 3138′ are a deviceattachment portion 3142, a rotary driver 3132, an approximating driver3144, and a screw alignment portion 3146. These components areconstructed and function in a similar fashion to the components of tool3138 described above. Tool 3138′ is constructed to allow one or morescrew holes to be formed in vivo, and/or allow screw(s) to be alignedwith such screw holes or preformed screw holes, throughflexible-to-rigid body portion 3114 of device 3100. Tool 3138′ may beconfigured to allow the screw hole(s) may be formed at an angle throughbody portion 3114, and/or formed perpendicularly to the longitudinalaxis of device 3100. Tool 3138′ may also include the capability to formscrew holes or align screws for insertion in the proximal hub portion ofdevice 3100 as described above.

Tool 3138′ may be used to form screw hole(s) in flexible-to-rigid bodyportion 3114 by guiding a drill bit with alignment tube 3168. Screwhole(s) may also be formed directly in body portion 3114 withoutpre-forming or drilling holes in vivo, but by placing a screw directlyinto body portion 3114, such as with a self-tapping screw guided withalignment tube 3168.

Internal components within device 3100, such as actuator 3126, may beconfigured such that screw(s) pass though it or pass around it. Forexample, in some embodiments the actuator comprises one or more cables,leaving enough room within body portion 3114 so that a screw can avoidthe actuator(s), or move it/them out of the way when passing into orthrough body portion 3114. In some embodiments, the one or moreactuators are large enough to allow one or more screws to pass throughit/them without impeding the operation of the actuator(s). In someembodiments, the screw(s) only enter one wall of tubular body portion3114 without entering the interior space of the body portion.

FIGS. 8 and 9 show alternative embodiments similar to device 3100described above. Device 3100′ shown in FIG. 8 is essentially identicalto device 3100 described above but is shorter in length and utilizes asingle anchor screw 3110 at its proximal end 3102. Device 3100″ shown inFIG. 9 is similar to device 3100′, but is shorter still. In variousembodiments, the devices may be configured to have a nominal diameter of3 mm, 4 mm, 5 mm or 6 mm. It is envisioned that all three device designs3100, 3100′ and 3100″ may each be provided in all three diameters suchthat the chosen device is suited for the particular fracture(s) andanatomy in which it is implanted.

FIGS. 10A-10I show another embodiment of a bone fixation deviceconstructed according to aspects of the invention. FIG. 10A is aperspective view showing the exemplary device 3200 deployed in afractured clavicle 3202. Device 3200 is similar to device 3100 describedabove and shown in FIGS. 1-7A, but has a gripper 3204 located near itsproximal end, another gripper 3206 located at a more distal location,and a flexible-to-rigid body portion 3208 located near the distal end ofthe device. A bone screw 3210 and gripper 3204 are configured to securedevice 3200 inside bone 3202 on the proximal side of fracture 3212,while gripper 3206 and flexible-to-rigid body portion 3208 areconfigured to secure device 3200 on the distal side of fracture 3212. Inother respects, construction and operation of device 3200 is much likethat of device 3100 described above.

In this exemplary embodiment, each of the two grippers 3204 and 3206 hasfour outwardly expanding arms 3214. These arms are spaced at 90 degreeintervals around the circumference of the device body. The arms 3214 ofgripper 3204 may be offset by 45 degrees from arms 3214 of gripper 3206as shown in the figures to distribute the forces applied by grippers3204 and 3206 on the bone 3202. As shown in FIGS. 10E and 10F, a singleactuator 3216 may be used to deploy both grippers 3204 and 3206.Actuator 3216 may also be used to axially compress flexible-to-rigidbody portion 3208 to make it substantially rigid. At least a portion ofactuator 3216 may be flexible to allow flexible-to-rigid body portion3208 to assume a curved shape, as seen in FIGS. 10A and 10B.Alternatively, it may be desirable in some embodiments to haveflexible-to-rigid body portion 3208 maintain a straight or a curvedconfiguration regardless of whether it is in a flexible or rigid state.In these embodiments, the actuator may be rigid and faulted with thedesired straight and/or curved shape to match the flexible-to-rigid bodyportion. In some embodiments, it may also be desirable to design atleast a portion of the actuator with a high degree of axial elasticityto allow the actuator to continue to expand some gripper(s) and/orcompress some flexible-to-rigid body portion(s) after other gripper(s)and/or flexible-to-rigid body portion(s) have already been fullydeployed.

Referring to FIGS. 10G-10I, further details of an exemplary gripper 3204are shown. FIGS. 10G and 10H show gripper 3204 with bendable arms 3214in a retracted state. As cam 3218 of actuator 3216 is driven axiallyinto the distal ramped ends of arms 3214, arms 3214 bend at thinnedportions 3220 to move radially outward toward the deployed positionshown in FIG. 10I. Notches 3222 may be provided in the distal ends ofarms 3214 as shown to allow arms 3214 to better grip interior bonesurfaces. Without departing from the scope of the invention, one, two,three, or more bendable arms may be used.

FIGS. 11 and 12 are perspective views of an embodiment of a bonefixation device 100 having a proximal end 102 (nearest the surgeon) anda distal end 104 (further from surgeon) and positioned within the bonespace of a patient according to the invention. In this example, device100 is configured to be implanted in the fibula, but otherconfigurations for other bony segments are contemplated. The proximalend and distal end, as used in this context, refers to the position ofan end of the device relative to the remainder of the device or theopposing end as it appears in the drawing. The proximal end can be usedto refer to the end manipulated by the user or physician. The distal endcan be used to refer to the end of the device that is inserted andadvanced within the bone and is furthest away from the physician. Aswill be appreciated by those skilled in the art, the use of proximal anddistal could change in another context, e.g. the anatomical context inwhich proximal and distal use the patient as reference, or where theentry point is distal from the surgeon.

When implanted within a patient, the device can be held in place withsuitable fasteners such as wire, screws, nails, bolts, nuts and/orwashers. The device 100 is used for fixation of fractures of theproximal or distal end of long bones such as intracapsular,intertrochanteric, intercervical, supracondular, or condular fracturesof the fibula; for fusion of a joint; or for surgical procedures thatinvolve cutting a bone. The devices 100 may be implanted or attachedthrough the skin so that a pulling force (traction may be applied to theskeletal system).

In the embodiment shown in FIG. 11, the design of the fixation device100 depicted is adapted to provide a bone engaging mechanism or gripper108 adapted to engage target bone of a patient from the inside of thebone. As configured for this anatomical application, the device 100 isdesigned to facilitate bone healing when placed in the intramedullaryspace within a post fractured bone. This device 100 has a gripper 108positioned distally and shown deployed radially outward against the wallof the intramedullary cavity. On entry into the cavity, gripper 108 isflat and retracted (FIG. 11). Upon deployment, gripper 108 pivotsradially outward and grips the diaphyseal bone from the inside of thebone. The device 100 can include a hub 112 comprising one or moreaperture 114, 116. One or more screws 110 placed through apertures 114,116 through the hub 112 lock the device 100 to the bone, as describedbelow. Hence, the metaphysis and the diaphysis are joined.

FIGS. 12-13 shows a perspective view of the device 100 in a deployedconfiguration. In this embodiment, gripper 108 includes three opposingbendable gripping members 118. Three bendable gripping members 118 areshown in FIG. 12, each located at the same axial location but offset by120 degrees. Each bendable gripping member 118 has a thinned portion 120that permits bending as the opposite distal end 122 of bendable grippingmember 118 is urged radially outward, such that bendable gripping member118 pivots about thinned portion 120. When extended, distal ends 122 ofbendable members 118 contact the inside of the bone to anchor the distalportion of device 100 to the bone. In alternative embodiments (notshown), the gripper may comprise 1, 2, 3, 4, 5, 6 or more bendablegripping members similar to bendable gripping members 118 shown.

FIG. 13 shows a hemispherical tip cover 134 may be provided at thedistal end 104 of the device 100 to act as a blunt obturator. Thisarrangement facilitates penetration of bone (e.g. an intramedullaryspace) by device 100 while keeping the tip of device 100 from digginginto bone during insertion.

FIG. 14 shows a longitudinal cross-sectional view of the device 100 in adeployed configuration. FIG. 15 shows the distal end of the device 100.During actuation, bendable gripping members 118 of gripper 108 are urgedradially outward by a ramped surface on actuator head 124. Actuator head124 is threaded onto the distal end of actuator 126. The proximal end ofactuator 126 has a keyed socket 130 for receiving the tip of the tip ofa screw driver through the proximal bore of device 100. In someembodiments, the keyed socket 130 is hex shaped. As screw driver turnsactuator 126, a threaded surface of the actuator 126 rotates in relationto the actuator head 124. This causes the actuator head 124 to be drawnin a proximal direction toward the proximal end 102 of the device 100 asthe actuator head 124 traverses the threaded surface of the actuator126. The ramped surface on the actuator head 124 outwardly actuatesbendable gripping members 118. The device 100 may include a stop toprevent translation of the actuator 126. The actuator 126 may includeone or more bends to match the shape of the device 100. The actuator may126 may be flexible or have a flexible portion between the keyed socket130 and the threaded surface. In other embodiments, the actuator 126 isintegrally formed with the actuator head 124. As a tool pulls theactuator 126, the actuator head 124 is drawn in a proximal directiontoward the proximal end 102 of the device 100. The ramped surface on theactuator head 124 outwardly actuates bendable gripping members 118.

FIG. 16A-C illustrates a method of inserting the screw 110 into theaperture 114. The screw 110 can be inserted with a combination tool,described herein. The screw 110 is aligned with the aperture 114. Insome embodiments, the screw 110 is oriented perpendicular to thelongitudinal axis of the hub 112. The aperture 114 has at least onedimension greater that the diameter of the screw 110. The at least onedimension can be aligned with the longitudinal axis of the hub 112and/or the longitudinal axis of the device 100. The aperture 114 can begenerally oblong, elliptical or tear shaped. The shape of the aperture114 allows the screw 110 to translate within the aperture 114. The screw110 can be inserted into the aperture 114 near the proximal end 102 ofthe device 100. The screw can be translated toward the distal end 104 ofthe device 100 while within the aperture 114. FIG. 16B shows the screw110 inserted in the aperture 114 near the proximal end 102 of the device100. FIG. 16C shows the screw 110 translated within the aperture 114toward the distal end 104 of the device 100.

FIGS. 17-19 shows a longitudinal cross-sectional view of the device 100of FIG. 16C after the screw 110 has been translated. A cap 128 can beprovided to maintain the position of the screw 110. The cap 128 canprevent the screw 110 from translating within the aperture 114 towardthe proximal end 102 of the device 100. The cap 128 can be insertedwithin the proximal bore of the device 100 until the distal end of thecap abuts the screw 110. The proximal bore can be threaded and the cap128 can include complementary threads. Other configurations of caps 128are contemplated.

FIG. 20 shows a perspective view of the device 100′. Device 100′ issubstantially similar to device 100 described above. The shape of thebody of the device 100′ has a different taper near the distal end of thehub 112′

FIGS. 21-22 shows a top and a side view of a combination tool 138 usefulfor inserting device 100, actuating gripper 108, approximating thefracture in bone, aligning one or more anchor screw(s) 110, and/orremoving device 100, if desired. The main components of tool 138 are ahub 158, a T-shaped body 140, a device attachment portion 142, a rotarydriver 132, and an alignment tube 168. The combination tool 138 can beassembled as follows.

Hub 158 is configured to abut the proximal end 102 of the device 100(seen in FIG. 22). In the embodiment shown, the proximal end 102includes a notch and the hub 158 includes a protrusion. Other matingconfigurations are contemplated. Hub 158 is coupled to the T-shaped body140. In some embodiments, the hub 158 is integrally formed with theT-shaped body 140. In the embodiment shown, hub 158 is coupled to theT-shaped body 140 with a lock (shown in FIG. 24). In this exemplaryembodiment, T-shaped body 140 couples with the hub 158 and can alsoserves as a handle.

Device attachment portion 142 prevents removal of the hub 158 and theT-shaped body from the device 100. Device attachment portion 142includes a knob 152 connected with a tube 160 (seen in FIG. 25-26). Inthe embodiment shown, the distal end of the tube 160 has a matingconfiguration 166 to engage the proximal bore of the device 100 (shownin FIG. 26). In the illustrated embodiments, the mating configuration166 is threads that engaging the threaded proximal bore of the device100. The knob 152 facilitates rotation of the tube 160. The tube 160 ofthe device attachment portion 142 is inserted into the hub 158 until themating configuration 166 of the tube 160 engages the proximal bore ofthe device 100. The tube 160 is partially inserted within proximal boreof the device 100 prior to inserting the screw 110. The tube 160 doesnot obstruct the aperture 114 prior to inserting the screw 110. Furtherrotation of the knob 152 causes the knob 152 to abut the T-shaped body140. The knob 152 of the device attachment portion 142 rigidly couplesthe hub 158 and the T-shaped body 140 with the device 100.

The rotary driver 132 can be partially inserted within the deviceattachment portion 142 prior to inserting the screw 110. The rotarydriver 132 can be inserted within the device attachment portion 142after inserting the screw 110. In some embodiments, the deviceattachment portion 142 has a lock that prevents translation of therotatory driver 132 prior to inserting the screw 110. The lock can bereleased by rotating the lock within the device attachment portion 142until the lock no longer prevents translation of the shaft 162. The lockcan ensure that the shaft 162 is not obstructing the aperture 114 priorto inserting the screw 110.

The alignment tube 168 is shown in FIGS. 21-23. The alignment tube 168can be coupled to the T-shaped body 140. The combination tool 138 is inplace when the device attachment portion 142 rigidly couples the hub 158and the T-shaped body 140 to the device 100. In this configuration, theremovable alignment tube 168 aligns with the proximal end of theaperture 114. In the embodiment depicted in the figures, the T-shapedbody 140 includes a plurality of bores 170, 172. In alternativeembodiments (not shown), a single bore or more than two bores may beused, with or without the use of separate alignment tube(s). thealignment tube 168 may include one or more slots. In the illustratedembodiment, the alignment tube 168 includes two longitudinally extendingslots 174. The alignment tube 168 can be oversized to create aninterference between the alignment tube 168 and the bore 170. The slots174 allow the alignment tube 168 to compress to fit within the bore 170.The design of the alignment tube 168 allows the alignment tube 168 to beretained within the T-shaped body 140 and be held rigidly in place.

In operation, alignment tube 168 is first received in bore 170 (seen inFIG. 21). In this position, alignment tube 168 is in axial alignmentwith aperture 114 at the proximal end 102 of device 100. As describedabove, the mating configuration of device 100 and hub 158 positionaperture 114 in its desired orientation. With this arrangement, a drillbit, screw driver, screw and/or other fastening device or tool may beinserted through the bore of alignment tube 168 such that the device(s)are properly aligned with aperture 114. The outward end of alignmenttube 168 may also serve as a depth guide to stop a drill bit, screwand/or other fastener from penetrating bone beyond a predetermineddepth. FIG. 22 shows alignment tube 168 with aperture 114 at the distalend of device 100, as described above. Inserting the screw 110 throughthe alignment tube 168 ensures that the screw 110 will have theplacement as shown in FIG. 16B. The alignment tube 168 allows properplacement of the screw 110 even if the aperture 114 or other portions ofthe device 100 are obstructed from the view of the surgeon.

The T-shaped body 140 includes other bores 172 that align with apertures116. Alignment tube 168 may be withdrawn from bore 170 as shown, andinserted in another bore 172. The alignment tube 168 can be insertedwithin these bores 172 to align and insert other screws 110 intoapertures 116. In this position, alignment tube 168 aligns with aperture116 of device 100. As described above, a drill bit, screw driver, screwand/or other fastening device may be inserted through the bore ofalignment tube 168 such that the device(s) are properly aligned withaperture 116.

FIGS. 23-24 show a screw 110 received through aperture 114. Screws 110may be installed manually or with the aid of tool 138 as describedabove. The heads of screws 110 may be configured to beself-countersinking such that they remain substantially beneath theouter surface of the bone when installed, as shown, so as to notinterfere with adjacent tissue. The rotatory driver 132 remainsstationary during insertion of the screw 110. The rotatory driver 132does not obstruct the aperture 114.

FIG. 25-26 show the rotatory driver 132 may be used to translate thescrew 110 within the aperture 114. In the embodiment shown, rotatorydriver 132 includes knob 154 and shaft 162. The distal end of shaft 162is provided with a mating configuration 164, such as threads, forengaging with device attachment portion 142. The mating configurationcan prevent disengagement between the device attachment portion 142 andthe rotatory driver 132. Suitable thread pitch and knob circumferencemay be selected to allow a surgeon to supply a desired force to thescrew 100 by using a reasonable rotation force on knob 154. In someembodiments, the threads are removed. The knob 154 can be translatedtoward the distal end 104 of the device 100 instead of rotating the knob154. The device attachment portion 142 can act as a bearing to align theshaft 126 with the proximal bore of the device 100. In alternativeembodiments (not shown), a torque indicating and/or torque limitingmechanism as described above may be incorporated into the deviceattachment portion 142 and/or rotatory driver 132.

Turning the knob 154 causes the shaft 162 to rotate and therebytranslate within the device attachment portion 142. Rotation of therotatory drive 132 causes the shaft 162 to translate toward the distalend 104 of the device 100 toward the screw 110. Further translation ofthe shaft 162 will push the screw 110 toward the distal end 104 of thedevice 100 while the screw 110 is within the aperture 114. Furtherrotation of the rotary driver 132 causes the screw 110 to translatewithin the aperture 114. The tool 138 is removed and the cap 128 isinserted within the proximal bore of the device 100. FIG. 16 shows theposition of the screw 110 after translation within the aperture 114.

The translation of the screw 110 may be used to compress one or morefractures in bone. FIG. 28A-28B illustrates a method of inserting thescrew 110 into the aperture 114 in relation to bone segments 2 and 4.Bone segment 2 is near the proximal end 102 of the device 100. Bonesegment 4 is near the distal end 104 of the device 100. The bone segment4 is held in place gripper 108 adapted to engage bone segment 4 from theinside of the bone. This device 100 has a gripper 108 positioneddistally and shown deployed radially outward against the wall of theintramedullary cavity. Upon deployment, gripper 108 pivots radiallyoutward and grips the diaphyseal bone from the inside of the bone. Theproximal bore of the device 100 is not obstructed by the bone screw 110allowing a screw driver to actuate the actuator 126 thereby translatingthe actuator head 124 (seen in FIG. 15). In the illustrated method, thegripper 108 engages bone segment 204 prior to insertion of the screw110. In other methods, the gripper 108 engages bone segment 204 afterinsertion of the screw 110 but prior to translation of the bone screw.

The screw 110 can be inserted with a combination tool 138. The screw 110is aligned with the aperture 114. In some embodiments, the screw 110 isoriented perpendicular to the longitudinal axis of bone. The screw 110penetrates bone segment 2. The screw 110 extends past the device 100 torigidly fix the screw 110 to the bone segment 2. The aperture 114 has atleast one dimension greater that the diameter of the screw 110. The atleast one dimension can be aligned with the longitudinal axis of thebone and/or the longitudinal axis of the device 100.

The screw 110 can be translated with respect to the aperture 114. Theshape of the aperture 114 allows the screw 110 to translate within theaperture 114. The screw 110 can be inserted into the aperture 114 nearthe proximal end 102 of the device 100. The screw can be translatedtoward the distal end 104 of the device 100 while within the aperture114. FIG. 28B shows the screw 110 translated within the aperture 114toward the distal end 104 of the device 100. The bone segment 2translates with the screw 110. With the bone segment 4 held in place bythe gripper 108, the translation of the screw 110 and the bone segment 2reduces the fractures and/or aligns the bone segments 4, 2. As screw 110is advanced axially toward bone segment 4, the screw 110 serves toapproximate bone fractures located between gripper 108 and screw 110.

Referring back to FIG. 23, additional screws (not shown) can be insertedinto the bores 172 and through the bone segments 2, 4 after translationof the screw 110 within the aperture 114. The bores 172 are aligned withthe other apertures 116 before and after the translation of the screw110 within the aperture 114. In the illustrated embodiment, theapertures 116 are substantially circular and do not permit theadditional screws to translate within the apertures 116. In theillustrated embodiments, the additional screws are inserted after thescrew 110 in translated within the aperture 114. In other embodiments(not shown), the apertures 116 are oblong and allow the additionalscrews to translate therewithin. The bone segment 2 in this embodimentwould have multiple points of fixation between screws and the bonesegments 2, 4 prior to translation.

In the illustrated embodiments, the distal end 104 is secured by gripper108. In this manner, any bone fractures located between the proximalscrew 110 and distal gripper 108 may be approximated and rigidly heldtogether by device 100. In alternative embodiments (not shown), morethan one gripper may be used. For example, the device shown in FIGS.28A-28B could be configured with a second gripper located betweengripper 108 and the middle of the device if the fracture is located moreat the mid-shaft of the bone. In alternative embodiments (not shown),screws or other fasteners may be used to secure the distal end 104 ofthe device 100 to the bone. Similarly, more than two screws or otherfasteners may be used, or only grippers without fasteners may be used.

Once device 100 is secured within bone 106, combination tool 138 may beremoved by turning device attachment portion 142 to disengage threads oftube 160 from threads within the proximal bore of device 100. The hub158 can be disengaged from the proximal end 102 of the device 100. Thecap 128 may be threaded into the proximal end 102 of device 100 topreventing growth of tissue into implanted device 100. Device 100 may beleft in bone permanently, or it may be removed by performing the abovedescribed steps in reverse. In particular, cap 128 is removed, tool 138is attached, one or more screws 110 are removed, gripper 108 isretracted, and device 100 is pulled out using tool 138.

FIG. 29 shows a perspective view of an embodiment of a screw driver 300.The screw driver 300 may be configured to engage the keyed socket 130 ofthe actuator 126 (seen in FIG. 14). The screw driver 300 may beconfigured to engage the keyed socket 148 of the screw 110 (seen in FIG.16A).

The screw driver 300 includes a proximal end 302 and a distal end 304.The proximal end 302 can have a mating configuration such as a flattenedsurface. The mating surface can engage a knob to facilitate rotation.The mating surface can engage a power source such a drill. The matingconfiguration can be a hand grip. The screw driver 300 can be sized andshaped to fit within the proximal bore of the device 100. The screwdriver 300 can be sized and shaped to fit within the alignment tube 168.

The distal end 304 includes a hex tip 306. All the hex flats 308 aresized to fit a female hex of the corresponding keyed socket 130, 148. Inthe illustrated embodiment, each flat 308 is 2.5 mm but other sizes arecontemplated. The hex tip 306 includes a slot 310 across one pair offlats 308. In the illustrated embodiment, the slot 310 bisects the pairof flats 308. In the illustrated embodiment, the slot 310 extends intothe screw driver 300, beyond the hex tip 306. The depth and width of theslot 310 depends on the retaining force with the actuator 126 or withthe screw 110.

The hex tip 306 is then deformed outward to create an interferencebetween the screw driver 300 and the keyed socket 130, 148. In theillustrated embodiment, the interference is on the order of 0.003″(e.g., 0.002″, 003″, 0.004″, 0.005″, between 0.002″ and 0.005″, etc.).The material of the screw driver 300 is selected maintain the deformedstate. One suitable material is heat treated stainless steel. Theconfiguration of the screw driver 300 prevents stripping of the keyedsocket 130, 148. In some embodiments (not shown), an elastomer could beinserted into the slot 310 to provide additional spring back if needed.

In accordance with the various embodiments of the present invention, thedevice may be made from a variety of materials such as metal, composite,plastic or amorphous materials, which include, but are not limited to,steel, stainless steel, cobalt chromium plated steel, titanium, nickeltitanium alloy (nitinol), superelastic alloy, and polymethylmethacrylate(PMMA). The device may also include other polymeric materials that arebiocompatible and provide mechanical strength, that include polymericmaterial with ability to carry and delivery therapeutic agents, thatinclude bioabsorbable properties, as well as composite materials andcomposite materials of titanium and polyetheretherketone (PEEK),composite materials of polymers and minerals, composite materials ofpolymers and glass fibers, composite materials of metal, polymer, andminerals.

Within the scope of the present invention, each of the aforementionedtypes of device may further be coated with proteins from synthetic oranimal source, or include collagen coated structures, and radioactive orbrachytherapy materials. Furthermore, the construction of the supportingframework or device may include radio-opaque markers or components thatassist in their location during and after placement in the bone or otherregion of the musculo-skeletal systems.

Further, the reinforcement device may, in one embodiment, be osteoincorporating, such that the reinforcement device may be integrated intothe bone. In a further embodiment, there is provided a low weight tovolume device deployed in conjunction with other suitable materials toform a composite structure in-situ. Examples of such suitable materialsmay include, but are not limited to, bone cement, high densitypolyethylene, Kapton™, polyetheretherketone (PEEK), and otherengineering polymers.

Once deployed, the device may be electrically, thermally, ormechanically passive or active at the deployed site within the body.Thus, for example, where the device includes nitinol, the shape of thedevice may be dynamically modified using thermal, electrical ormechanical manipulation. For example, the nitinol device may be expandedor contracted once deployed, to move the bone or other region of themusculo-skeletal system or area of the anatomy by using one or more ofthermal, electrical or mechanical approaches.

FIGS. 31A-31H show the anatomy of the fibula. The fibula is a leg bonelocated below the knee. The fibula is connected to the tibia and is theslenderest of the long bones in the human body. The arrow shows theentry point of the device within the patient. The distal end 104 wouldextend toward the knee in the intramedullary canal. The proximal end 102would be toward the ankle.

FIGS. 32A-32J are various method steps to implant the device of FIGS.1-30. FIGS. 32A-32J shows the device 100 and the tool 138, but any ofthe devices described herein can be inserted using one or more of thefollowing method steps.

FIG. 32A shows the assembled tool 138 useful for inserting device 100(not shown) into bone. Hub 158 is configured to abut the proximal end102 of the device 100. Hub 158 is coupled to the T-shaped body 140.Device attachment portion 142 prevents removal of the hub 158 and theT-shaped body from the device 100. Device attachment portion 142includes a knob 152 that abut the T-shaped body 140. The knob 152 of thedevice attachment portion 142 rigidly couples the hub 158 and theT-shaped body 140 with the device 100. Screwdriver 155 can be insertedinto the knob 152 of the device attachment portion 142. The assembledtool 138 is shown removed from the bone in FIG. 22.

FIG. 32B shows a cross-sectional view of the inserted device 100. Thedevice 100 is inserted into the fibula. In some methods, T-shaped body140 can serve as a handle to facilitate insertion of the device 100. Inother methods, knob 152, knob 154 (not shown) and or screwdriver 155 areused to facilitate insertion of the device 100.

Distal end 104 of device 100 can be inserted into the bone before theproximal end 102 of the device 100. Device 100 is inserted into bonesegments 2 and 4. Bone segment 2 is near the proximal end 102 of thedevice 100 and bone segment 4 is near the distal end 104 of the device100.

Device 100 is in the undeployed state during insertion. In theundeployed state, gripper 108 is not actuated by actuator 126. Distalends 122 of bendable gripping members 118 do not contact the inside ofthe bone to anchor the distal portion 104 of device 100 to the bone.Device 100 can remain in the undeployed state until the fracture isreduced. The device 100 is inserted into the bone until the device 100is inserted into both bone segments 2, 4 and therefore spans thefracture.

In the illustrated embodiment, the bone is a fibula. Bone segment 2 isthe distal portion of the fibula and bone segment 4 is a proximalsegment of the fibula. In other methods, bone segment 2 is the proximalportion of the fibula and bone segment 4 is a distal segment of thefibula. The method described herein can be used with other bones, suchas the femur, humerus, tibia, radius, ulna, and clavicle.

In some methods, the insertion of the device 100 does not align thefracture. For instance, one fragment of the bone (e.g., bone segment 2)may not be aligned with another fragment of the bone (e.g., bone segment204). Further manipulation of the bone segment 2 and/or the bone segment204 may be necessary. In some factures, the bone segments 2, 4 may bemisaligned posteriorly or anteriorly, as those terms are commonlyunderstood anatomically. In some factures, the bone segments 2, 4 may bemisaligned distally or proximally, as those terms are commonlyunderstood anatomically.

FIG. 32C shows the use of K-wires 178 to reduce the fracture. K-wires178 can be inserted into bone segment 2. T-shaped body 140 includesbores 176 sized to accept K-wires 178. Bores 176 are also shown in FIG.21. K-wires 178 are inserted through bores 176 and into the bone segment2. In the illustrated embodiment, bone segment 2 is the distal portionof the fibula. In other methods, the K-wires may be inserted into bonesegment 4. K-wires may be inserted one or more bone segments (bonesegment 2, bone segment 4, additional bone segments). In the illustratedmethod, two K-wires 178 are inserted into bone segment 2, but any numberof K-wires 178 can be used (e.g., one, two, three, four, five, six,etc.). In the illustrated method, K-wires 178 are substantiallyparallel, but other configures are possible. K-wires 178 may be coaxial,coplanar, parallel, perpendicular, skewed, or any other configuration.

Bores 176 and thus K-wires 178 inserted through bores 176 are positionedon either side of a proximal-distal line. K-wires 178 pass through thebone segment 2 on either side of the device 100. In some methods, one ormore K-wires 178 pass on the anterior side of the device 100. In somemethods, one or more K-wires 178 pass on the posterior side of thedevice 100. The location and number of K-wires will depend on the natureof the fracture.

FIG. 32D shows the insertion of the K-wires 178 into the bone segment 2.Movement of K-wires 178 can cause movement of bone segment 2. In somemethods, T-shaped body 140 can also serve as a handle to facilitatemovement of K-wires 178. In other methods, knob 152 is used tofacilitate movement of K-wires 178. In some methods, K-wires 178 andbone segment 2 are pulled away from the bone segment 4 to increase thegap between bone segments 2, 4. In some methods, K-wires 178 and bonesegment 2 are pushed toward the bone segment 4 to decrease the gapbetween bone segments 2, 4. In some methods, K-wires 178 and bonesegment 2 are rotated relative to the bone segment 4 to alter the gapbetween bone segments 2, 4. In some methods, the device 100 remainspositioned with bone segments 2, 4 during this motion to align bonesegments 2, 4. FIGS. 32E-32F show the fracture is reduced. Bymanipulating (e.g., pulling, pushing, twisting) the K-wires 178, thefracture can be manually reduced.

In some methods it is desirable to maintain the position of the bonesegments 2, 4. In some methods, one or more K-wires 178 are driventhrough the bone segment 2. K-wires 178 can be driven into the talus(not shown) to maintain the position of the bone segment 2. K-wires 178can be driven into any stable surface to maintain the position.

FIG. 32G shows that in some methods, the gripper 108 is deployed tomaintain the position of one or more the bone segments 2, 4. In somemethods, gripper 108 can be deployed to maintain the position of bonesegment 4. In some methods, the gripper 108 is not deployed until thefracture is reduced by manipulating the K-wires 178. In some methods,the gripper 108 is deployed prior to manipulating the K-wires 178. Insome methods, the gripper 108 is deployed during manipulation of theK-wires 178.

During actuation, bendable gripping members 118 of gripper 108 are urgedradially outward by a ramped surface on actuator head 124. Actuator head124 is threaded onto the distal end of actuator 126. As screw driver 155turns actuator 126, a threaded surface of the actuator 126 rotates inrelation to the actuator head 124. This causes the actuator head 124 tobe drawn in a proximal direction toward the proximal end 102 of thedevice 100 as the actuator head 124 traverses the threaded surface ofthe actuator 126. The ramped surface on the actuator head 124 outwardlyactuates gripper members 118. The device 100 may include a stop toprevent translation of the actuator 126. Gripper 108 is deployed in thebone segment 4 to lock the position of the device 100. FIG. 32G showsthe method of immobilizing both bone segments 2, 4. Gripper 108prohibits movement of the bone segment 4. K-wires 178 prohibit movementof bone segment 2. FIGS. 32H-32J show various views of the bone with thedevice 100.

In some methods, screw 110 (not shown) is inserted into aperture 114 ofdevice 100. Screw 110 may be guided by removable alignment tube 168 asshown in FIG. 23. Screw 110 can be coupled to the bone segment 2 duringinsertion of screw 110. In the illustrated embodiments, screw 110 willextend transverse to the device 100. In some methods, one or moreK-wires 178 remain in place while the screw 110 is inserted. Screw 110can be located within the aperture 114 and coupled to the bone segment2.

The bone segments 2, 4 have been previously aligned by manipulatingK-wires 178. In some methods, shaft 162 (FIG. 26) is translated towardthe distal end 104 of the device 100 toward the screw 110. Furthertranslation of shaft 162 will push screw 110 and bone segment 2. Furtherrotation of the rotary driver 132 causes the screw 110 to translatewithin the aperture 114. Screw 110 and bone segment 2 can be pushedtoward the distal end 104 of the device 100. As screw 110 is advancedtoward bone segment 4, screw 110 functions to approximate the bonefracture. In some methods, K-wires 178 translate when the screw 110 istranslated. In some methods, T-shaped body 140 and K-wires 178 translatewhen the screw 110 is translated.

FIGS. 33A-33G are various method steps to implant the device of FIGS.1-30. FIGS. 33A-33G shows the device 100, but any of the devicesdescribed herein can be inserted using one or more of the followingmethod steps. FIG. 33A shows a fibula fracture. Typical fibula fracturesresult in a compressed and rotated bone fragments. Bone segment 2 is thedistal fragment of the fibula and bone segment 4 is the proximalfragment of the fibula. In other methods, bone segment 2 is the proximalfragment of the fibula and bone segment 4 is a distal fragment of thefibula.

FIG. 33B shows a Hintermann style distractor 180. The Hintermann styledistractor 180 can separate the compressed bone segments 2, 4 byactuating the handles. The Hintermann style distractor 180 can rotatethe bone segments 2, 4 by deforming the K-wires 178 relative to eachother. K-wires 178 inserted through the Hintermann style distractor 180are position on either side of a proximal-distal line. K-wires 178 passthrough the bone segments 2, 4 on either side of the device 100. In somemethods, one or more K-wires 178 pass on the anterior side of the device100. In some methods, one or more K-wires 178 pass on the posterior sideof the device 100. The location and number of K-wires will depend on thenature of the fracture. FIG. 33C shows the fracture is reduced bydistracting the bone segments 2, 4 and if necessary rotating the bonesegments 2, 4 relative to each other.

In some methods it is desirable prepare the bone segments 2, 4 for thedevice 100. FIGS. 33D-33E shows the insertion of a reamer 182 to preparethe bone segments 2, 4. In one embodiment, a reamer is a drill. In somemethods, a reamer 182 is driven through the bone segments 2, 4.Strategic placement of the K-wires 178 allows the reamer 182 to passthrough the bone segments 2, 4 without interfering with the K-wires 178.

FIG. 33F shows an embodiment of the reamer 182. The reamer 182 has aproximal end and a distal end. The distal end can include at least onespiral cutting edge having a first diameter. The proximal end caninclude a handle. In some embodiments, the handle can be manipulated bya user. In some embodiments, the handle can be coupled to a power tool.A portion of the shaft of the reamer 182 has a diameter less than thefirst diameter (e.g., an area of reduced diameter). In some embodiments,the reamer 182 includes a through lumen. The through lumen of the reamer182 can be inserted over a guiding wire. The shank of the reamer 182 canhave a reduced diameter to increase the flexibility. In someembodiments, a radiographic depth indicator on the shank indicates whenthe proper drilling depth is achieved.

FIG. 33G shows the implant 100 (not shown) can be inserted with thecombination tool 138 while maintaining the reduction with the Hintermannstyle distractor 180. In some methods, T-shaped body 140 can also serveas a handle to facilitate insertion of the device 100. Grippers 108 canbe deployed (as shown in FIGS. 32G-32I). Screw 110 may be guided throughthe device 100. In some methods, shaft 162 (FIG. 26) is translatedtoward the distal end 104 of the device 100 toward the screw 110, asdescribed herein.

FIGS. 34A-34D are various method steps to implant the device of FIGS.1-30. FIGS. 34A-34D shows the device 100, but any of the devicesdescribed herein can be inserted using one or more of the followingmethod steps. FIG. 34A shows an alternative style distractor 184. Thisdistractor 184 can allow rotation of the bone segment 2 withoutrequiring wire deformation of one or more K-wires 178. FIGS. 34A and 34Cshow a compressed and rotated bone segment 2. Knob 186 of distractor 184can be rotated to rotate the bone segment 2. FIGS. 34A and 34C show thebone segment 2 in the original position. FIGS. 34B and 34D show the bonesegment 2 rotated to a new position.

FIGS. 35A and 35B are perspective views of an embodiment of a bonefixation device 200 having a proximal end 202 (nearest the surgeon) anda distal end 204 (further from surgeon) and positioned within the bonespace of a patient according to the invention. The bone fixation device200 can be similar to bone fixation device 100, and can include anyfeature or combination of features described herein. In this example,device 200 is configured to be implanted in the fibula, but otherconfigurations for other bony segments are contemplated. The proximalend and distal end, as used in this context, refers to the position ofan end of the device relative to the remainder of the device or theopposing end as it appears in the drawing. The proximal end can be usedto refer to the end manipulated by the user or physician. The distal endcan be used to refer to the end of the device that is inserted andadvanced within the bone and is furthest away from the physician. Aswill be appreciated by those skilled in the art, the use of proximal anddistal could change in another context, e.g. the anatomical context inwhich proximal and distal use the patient as reference, or where theentry point is distal from the surgeon.

When implanted within a patient, the device can be held in place withsuitable fasteners such as wire, screws, nails, bolts, nuts and/orwashers. The device 200 is used for fixation of fractures of theproximal or distal end of long bones such as intracapsular,intertrochanteric, intercervical, supracondular, or condular fracturesof the fibula; for fusion of a joint; or for surgical procedures thatinvolve cutting a bone. The devices 200 may be implanted or attachedthrough the skin so that a pulling force (traction may be applied to theskeletal system).

The design of the fixation device 200 depicted is adapted to provide abone engaging mechanism or gripper 208 adapted to engage target bone ofa patient from the inside of the bone. As configured for this anatomicalapplication, the device 200 is designed to facilitate bone healing whenplaced in the intramedullary space within a post fractured bone. Thisdevice 200 has a gripper 208 positioned distally and shown deployedradially outward against the wall of the intramedullary cavity in FIG.36. On entry into the cavity, gripper 208 is flat and retracted, asdescribed herein. Upon deployment, gripper 208 pivots radially outwardand grips the diaphyseal bone from the inside of the bone.

FIG. 35B shows a perspective view of the device 200 in a deployedconfiguration. In this embodiment, gripper 208 includes opposingbendable gripping members 218. The bendable gripping members 218 can bereferred to as talons. Three bendable gripping members 218 are shown inFIG. 36, but other configurations are contemplated. Each bendablegripping member 218 is located at the same axial location but offset by120 degrees. Each bendable gripping member 218 has a thinned portion 220that permits bending as the opposite distal end 222 of bendable grippingmember 218 is urged radially outward, such that bendable gripping member218 pivots about thinned portion 220. When extended, distal ends 222 ofbendable members 218 contact the inside of the bone to anchor the distalportion of device 200 to the bone, as shown in FIG. 36. The device 200has triangular bendable gripping members 218 which are ideal forfixation in the triangular fibula canal. The bone canal can be any shapeincluding circular, non-circular or triangular. The gripper 208 can haveany shape gripping members 218 to correspond with the anatomical canal.In alternative embodiments (not shown), the gripper may comprise 1, 2,3, 4, 5, 6 or more bendable gripping members similar to bendablegripping members 218 shown.

FIG. 35B shows a hemispherical tip cover 234 may be provided at thedistal end 204 of the device 200 to act as a blunt obturator. Thisarrangement facilitates penetration of bone (e.g. an intramedullaryspace) by device 200 while keeping the tip of device 200 from digginginto bone during insertion.

FIG. 37 shows a longitudinal cross-section of device 200 in a deployedconfiguration. The device 200 includes an actuator 226 to deploy thedevice 200 from a un-deployed configuration to the deployedconfiguration. The actuator 226 interacts with the bendable grippingmembers 218 to splay the bendable gripping members 218 outward from thedevice 200.

FIGS. 38A-38D show various views of the device 200. The device 200 caninclude a hub 212 comprising one or more aperture 10, 12, 14, 16, 18.Each aperture 10, 12, 14, 16, 18 has an angle corresponding to theanatomy of the patient. Some apertures accept one type or length ofscrew. Some apertures accept another type or length of screw. One ormore screws 20, 22 are placed through apertures 10, 12, 14, 16, 18through the hub 212 to lock the device 200 to the bone, as describedbelow. Hence, the metaphysis and the diaphysis are joined.

The screws 20 are distal screws. The screws 20 have a length between 12mm and 20 mm. The screws 20 have a diameter of 2.7 mm. The screws 20 arelocking screws. The screws 20 engage cortical bone. The screws 20 aremulti-planar. The screws 20 are locking screws which can resistback-out. Multi-planar screws 20 are stronger in pull out, torsions,tension and compression. Two screws 20 can have the same orientation.Aperture 10 and 14 can have the same orientation. Apertures 10 and 14can position screws 20 in the lateral-medial directions, as describedherein. One screws 20 can have a different orientation. Aperture 12 canhave a different orientation than apertures 10 and 14. Apertures 12 canposition screw 20 in the anterior-posterior direction. The aperture 12is externally rotated in relation to the transepicondylar axis. Theaperture 12 is rotated anteriorly from the coronal plane. The screw 20through aperture 12 is placed obliquely an angle alpha. The angle alphais approximately 60 degrees from anteromedial to posterolateral in thetransverse plane. The aperture 12 is oriented 60 degree anteriorly.

In alternative embodiments (not shown), the device may comprise a 40degree, 45 degree, 50 degree, 55 degree, 60 degree, 65 degree, 70degree, 75 degree, 80 degree, or different anterior angle similar toangle of the aperture 12 shown. The aperture 12, may form an anteriorangle of, for example, approximately 30 degrees, approximately 35degrees, approximately 40 degrees, approximately 45 degrees,approximately 50 degrees, approximately 55 degrees, approximately 60degrees, approximately 65 degrees, approximately 70 degrees,approximately 75 degrees, approximately 80 degrees, approximately 85degrees, approximately 90 degrees etc. The aperture 12, may form anangle of, for example, between 50-60 degrees, between 55-65 degrees,between 60-70 degrees, between 65-75 degrees, etc. The aperture 12, mayform an angle of, for example, between 40-60 degrees, between 45-65degrees, between 50-70 degrees, between 55-75 degrees, between 60-80degrees, between 65-85 degrees etc. The aperture 12, may form an angleof, for example, between 50-70 degrees, between 45-75 degrees, orbetween 40-80 degrees, etc.

The screws 22 are syndesmotic screws. The screws 22 have a lengthbetween 40 mm and 70 mm. The screws 22 have a diameter of 3.5 mm. Thescrews 22 are non-locking screws. The screws 22 engage cortical bone.The screws 22 are double-lead threads, which rotate twice as fast toengage bone. FIG. 38A shows three screws 20 and two screws 22, but otherconfigurations are contemplated. In alternative embodiments (not shown),the device may comprise 1, 2, 3, 4, 5, 6 or more screws similar to screw20 shown. In alternative embodiments (not shown), the device maycomprise 1, 2, 3, 4, 5, 6 or more screws similar to screw 22 shown.Aperture 16 and 18 can have the same orientation. Apertures 16 and 18can position screws 22, as described herein. The apertures 16 and 18 areexternally rotated in relation to the transepicondylar axis. Theapertures 16 and 18 are rotated posteriorly from the coronal plane. Theaperture 12 can position the screw 20 in an opposite direction from thecoronal plane than the apertures 16 and 18. The screws 22 are placedobliquely an angle beta. The angle is approximately 25 degrees fromposterolateral to anteromedial in the transverse plane. The apertures 16and 18 are oriented 25 degree posteriorly.

In alternative embodiments (not shown), the device may comprise 10degree, 15 degree, 20 degree, 25 degree, 30 degree, 35 degree, 40degree, 45 degree, 50 degree, or different degree posteriorangle similarto angle of the apertures 16 and 18 shown. The apertures 16 and 18, mayform a posterior angle of, for example, approximately 10 degrees,approximately 15 degrees, approximately 20 degrees, approximately 25degrees, approximately 30 degrees, approximately 35 degrees,approximately 40 degrees, approximately 45 degrees, approximately 50degrees, etc. The apertures 16 and 18, may form a posterior angle of,for example, between 15-25 degrees, between 20-30 degrees, between 25-35degrees, between 30-40 degrees, etc. The apertures 16 and 18, may form aposterior angle of, for example, between 5-25 degrees, between 10-30degrees, between 15-35 degrees, between 20-40 degrees, between 25-45degrees, or between 30-50 degrees, etc. The apertures 16 and 18, mayform a posterior angle of, for example, between 20-30 degrees, between15-35 degrees, between 10-40 degrees, or between 5-45 degrees, etc.

The device 200 has a 6 degree bend between the hub 212 and the distalend 204 as shown in FIG. 38B. In alternative embodiments (not shown),the device may comprise 1 degree, 2 degree, 3 degree, 4 degree, 5degree, 6 degree, 7 degree, 8 degree, 9 degree, 10 degree, 11 degree, 12degree, 13 degree, 14 degree, 15 degree, or different degree bendsimilar to bend shown. The device 200 has a left configuration and aright configuration. For two proximal diameters (3 mm, 3.8 mm) andlengths (130 mm, 180 mm), there are many possible configurations (e.g.,3 mm×130 mm left and right, 3.8 mm×130 mm left and right, 3 mm×180 mmleft and right, 3.8 mm×180 mm left and right).

FIGS. 39A-39B show other views of the screws 20, 22. The apertures 16and 18 are 25 degree anteriorly. The aperture 12 has a 30 degreeorientation from directly anterior.

FIG. 40 illustrates a method of inserting a compression screw 24 into anaperture 10. The compression screw 24 can be substantially similar oridentical to screw 20. The screw 24 can be inserted with a combinationtool, described herein. The screw 24 is aligned with the aperture 10. Insome embodiments, the screw 24 is oriented perpendicular to thelongitudinal axis of the hub 212. The aperture 10 has at least onedimension greater that the diameter of the screw 24. The at least onedimension can be aligned with the longitudinal axis of the hub 212and/or the longitudinal axis of the device 200. The aperture 10 can begenerally oblong, elliptical or tear shaped. The shape of the aperture10 allows the screw 24 to translate within the aperture 8. The screw 24can be inserted into the aperture 10 near the proximal end 202 of thedevice 200. The screw can be translated toward the distal end 204 of thedevice 200 while within the aperture 8. FIG. 40A shows the screw 24inserted in the aperture 10 near the proximal end 202 of the device 200.FIG. 40 shows the screw 24 translated within the aperture 10 toward thedistal end 204 of the device 200. In alternative embodiments (notshown), the screw 24 translates automatically due to the shape of theaperture 8. As the screw 24 is rotated, the screw 24 encountersresistance of the aperture 8. In order to continue to rotate, the screw24 translates itself within the aperture 10 toward the distal end 204 ofthe device 200.

FIGS. 41A-41B show syndesmosis fixation. The screws 22 are syndesmoticscrews, as described herein. The screws 22 are parallel to the anklejoint. The screws 22 are anatomically oriented 25 degrees anteriorly.The screws 22 are anatomically oriented. FIG. 42 shows the anatomicaljoint. The fibula sits posterior to the tibia. The fibula is connectedto the tibia by the syndesmosis ligament. The syndesmosis ligament iscomprised of the anterior tibiofibular ligament, the posteriortibiofibular ligament and the interosseous membrane. The syndesmosisjoint is where the fibular incisura notch in the tibia meets thefibular. Referring back to FIGS. 41A-41B, the angle of the screws 22reduces syndesmotic injury anatomically.

FIGS. 43A-43B shows data from a study. In some methods of use,transsyndesmotic screws are placed obliquely 30° from posterolateral toanteromedial in the transverse plane. Thirty-eight CT scans of therelevant anatomy were used to examine the rotational profile of the axisof the syndesmotic joint in relation to the transepicondylar axis. FIG.43A shows a line drawn between the femoral epicondyles. FIG. 43B showsthe rotation of the syndesmosis 10 mm superior to the ankle joint. FIG.43C shows syndesmosis rotation superimposed on the transepicondylaraxis. The average angle was 32°±6°. In other words, the axis of thedistal tibiofibular joint was 32°±6° externally rotated in relation tothe transepicondylar axis. This study demonstrates that the axis of theuninjured distal tibiofibular joint is approximately 30° externallyrotated in relation to the transepicondylar axis.

FIGS. 44A-44S are various method steps to implant the device 200 ofFIGS. 35-41B. FIGS. 44A-44S shows the device 200, but any of the devicesdescribed herein can be inserted using one or more of the followingmethod steps.

FIG. 44A shows the method step of reducing the fracture. The lateralmalleolus are reduced percutaneously before reaming. A tool 402 such asthe clamp shown in FIG. 44A is used to reduce the fracture. Othercommercially available tools can be utilized to reposition and/or holdthe fracture.

FIG. 44B shows the method step of establishing an entry point. Thesurgeon can align the entry point with the long axis of the fibula inthe lateral view. The surgeon can aim for the canal center in theanterior/posterior view. A K-wire 404 is driven across the fractureline. A tool 406 such as the inserter shown in FIG. 44B and/or thecannula 408 is used to position the K-wire. Other commercially availabletools can be utilized to insert a K-wire across the fracture line.

FIG. 44C shows the method step of preparing the fibula. The surgeon candrive a tapered reamer 410 over the K-wire 404. The reamer 410 can beplaced through the cannula 408. The diameter of the reamer is 6.2 mm.Other commercially available tools can be utilized to ream the distalportion of the fibula. The surgeon can drive a flexible guide wire 412through the reamer into the proximal fibula. FIG. 44D shows the insertedguide wire 412.

FIG. 44E shows the method step of preparing the fibula. The surgeon cansequentially ream the proximal fibula. The surgeon can use one or moreproximal reamers 414. The proximal reamers 414 can be driven over theguide wire 412. The proximal reamer 414 can be placed through thecannula 408. The proximal reamer 414 can be flexible. Other commerciallyavailable tools can be utilized to ream the fibula.

FIG. 44F shows the method step of inserting an insertion guide 416. Theinsertion guide 416 can be driven over the guide wire 412. The insertionguide 416 has an inner cannula 418. Other commercially available toolscan be utilized to insert the implant. FIG. 44G shows the method step ofremoving the inner cannula 418 of the insertion guide 416. The guidewire 412 is also removed. The insertion guide 416 can be a portion of acircular cross-section.

FIG. 44H shows the method step of inserting the bone fixation device 200through the insertion guide 416. Other commercially available tools canbe utilized to insert the device 200. The insertion guide 416 cansupport and guide the bone fixation device 200. The insertion guide 416can surround a portion of the bone fixation device 200 during insertion.The tool 238 can be coupled to the bone fixation device 200 duringinsertion. The tool 238 can include apertures aligned with apertures 10,12, 14, 16, 18 as described herein.

FIG. 44I shows the method step of confirming the depth of insertion ofthe bone fixation device 200. The stylet 420 is inserted through thetool 238. The stylet 420 can be inserted toward the proximal end 202 ofthe bone fixation device 200. The stylet 420 can confirm the location ofthe most proximal edge of the bone fixation device 200.

FIG. 44J shows the method step of actuating the gripper 208 as describedherein. During actuation, bendable gripping members 218 of gripper 208are urged radially outward by an actuator 226 (not shown). The actuator226 is drawn in a proximal direction toward the proximal end 202 of thebone fixation device 200. The ramped surface on the actuator 226outwardly actuates gripper members 218. Gripper 208 is deployed in thebone to lock the position of the bone fixation device 200.

FIGS. 44K-44M shows the methods steps of placing the compression screw24 as described herein. In some methods, a drill 422 is inserted into anaperture in the tool 238 as shown in FIG. 44K. The drill 422 prepares apilot hole in the bone and/or through the aperture 10 (see FIG. 44M).The screw 24 is inserted into aperture 10 of device 200 (see FIG. 44M).Screw 24 may be guided by a tool such as a screwdriver 424 as shown inFIG. 44L. In the illustrated embodiments, screw 24 will extendtransverse to the device 200. Screw 24 can be located within theaperture 10 and coupled to the bone segment, as shown in FIG. 44M. Thefracture may have been previously aligned. In some methods, shaft 262 istranslated toward the distal end 204 of the device 200 toward the screw24. Further translation of shaft 262 will push screw 24 and the bonesegment connected to the screw 24. The screw 24 translates within theaperture 8. Screw 24 and the attached bone segment can be pushed towardthe distal end 204 of the device 200. As screw 24 is advanced toward thedistal end 204, screw 24 functions to approximate the bone fracture.

FIG. 44N show the methods step of placing the screws 20, 22 as describedherein. The tool 238 can include apertures 10′ 12′, 14′, 16′, 18′aligned with apertures 10, 12, 14, 16, 18. Screw 20, 24 is insertedwithin aperture 10. Screw 20 is inserted within aperture 12. Screw 20 isinserted within aperture 14. Screw 22 is inserted within aperture 16.Screw 22 is inserted within aperture 18. The screws 20, 22, 24 can beinserted sequentially. One or more screws 20, 22, 24 can be insertedsimultaneously. The surgeon can inserted the screws 20, 22 in the orderbest suited for the surgical procedure. The surgeon can insert thescrews 22 in either a right orientation or a left orientation dependingon the leg being operated on. The surgeon can insert the screw 20, 24 inaperture 12 in either a right orientation or a left orientationdepending on the leg being operated on. The screws 20, 24 in apertures10, 14 may be universally located for both the right leg and the leftleg.

FIG. 44O show the methods step of placing the endcap 228. The endcap 228can prevent encroachment of tissue and/or bone in the lumen of thedevice 200. The cap 228 can be provided to maintain the position of thescrew 24, similar to the endcap 128 shown in FIG. 27. The cap 228 canprevent the screw 24 from translating within the aperture 10 toward theproximal end 202 of the device 200. The cap 228 can be inserted withinthe proximal bore of the device 200 until the distal end of the capabuts the screw 24. The proximal bore can be threaded and the cap 228can include complementary threads. Other configurations of caps 228 arecontemplated.

FIG. 44P shows the orientation of the device 200 within the bone. Whileonly one screw 22 is shown, more screws 22 can be positioned within thebone.

FIGS. 44Q-44S show the method step of utilizing other fasteners forsecuring the syndesmosis. FIG. 44Q shows the method step of forming ahole. The reamer 426 can pass through aperture 16 or 18 of the device.The reamer can form a hole through bone aligned with aperture 16 or 18.The diameter of the hole is 3.5 mm. FIG. 44R shows the method step ofpassing a suture bundle through the hole. The suture bundle can guidethe fastener 26. The fastener 26 can be similar to commerciallyavailable fasteners. FIG. 44S shows the orientation of the device 200with the fastener 26. While only one fastener 26 is shown, morefasteners can be positioned within the bone.

FIG. 45A show the reamer 410. The reamer 410 shown in FIG. 45A is usedto perform method step shown in 44C. The reamer 410 is tapered. Thereamer 410 can have a central lumen (not shown) to accept a K-wire orflexible guide wire. The diameter of the reamer 410 is 6.2 mm.

FIG. 44B show the reamer 414. The reamer 414 shown in FIG. 44B is usedto perform method step shown in FIG. 44E. The reamer 414 can have acentral lumen (not shown) to accept a guide wire. The proximal reamer414 can be flexible.

FIGS. 45C-45D show the assembled tool 238 useful for inserting device200 into bone. Hub 258 is configured to abut the proximal end 202 of thedevice 200. Hub 258 is coupled to the T-shaped body 240. Deviceattachment portion 242 prevents removal of the hub 258 and the T-shapedbody from the device 200. Device attachment portion 242 includes a knob252 that abut the T-shaped body 240. The knob 252 of the deviceattachment portion 242 rigidly couples the hub 258 and the T-shaped body240 with the device 200. The assembled tool 238 is shown removed fromthe bone in FIG. 45C. FIG. 45D shows a view of the inserted device 200.The device 200 is inserted into the fibula. In some methods, T-shapedbody 240 can serve as a handle to facilitate insertion of the device200.

Distal end 204 of device 200 can be inserted into the bone before theproximal end 202 of the device 200. Device 200 is in the un-deployedstate during insertion as shown in FIG. 45C. In the undeployed state,gripper 208 is not actuated by actuator 226. Distal ends 222 of bendablegripping members 218 do not contact the inside of the bone to anchor thedistal portion 204 of device 200 to the bone. Device 200 can remain inthe un-deployed state until the fracture is reduced. FIG. 45D shows thatin some methods, the gripper 208 is deployed to maintain the position ofone or more the bone segments. Typical fibula fractures result in acompressed and rotated bone fragments.

FIG. 45D shows the implant 200 can be inserted with the combination tool138. In some methods, T-shaped body 240 can also serve as a handle tofacilitate insertion of the device 200. Grippers 208 can be deployed (asshown in FIG. 45D). Screws 20 may be guided through the device 200.Screws 22 may be guided through the device 200.

FIGS. 45E-45H show an embodiment of the actuator 226. During actuation,bendable gripping members 218 of gripper 208 are urged radially outwardby a ramped surface on actuator head 224. Actuator head 224 is threadedonto the distal end of actuator 226. The proximal end of actuator 226has a keyed socket 230 for receiving the tip of the tip of a screwdriver through the proximal bore of device 200. In some embodiments, thekeyed socket 230 is hex shaped. As screw driver turns actuator 226, athreaded surface of the actuator 226 rotates in relation to the actuatorhead 224. This causes the actuator head 224 to be drawn in a proximaldirection toward the proximal end 202 of the device 200 as the actuatorhead 224 traverses the threaded surface of the actuator 226. The rampedsurface on the actuator head 224 outwardly actuates bendable grippingmembers 218. The device 200 may include a stop to prevent translation ofthe actuator 226. The actuator 226 may include one or more bends tomatch the shape of the device 200. The actuator 226 may be flexible orhave a flexible portion between the keyed socket 230 and the threadedsurface.

FIGS. 45I-45J show a perspective view of an embodiment of a screw driver320. The screw driver 320 may be configured to engage the keyed socket130 of the actuator 126 (shown in FIG. 14) or the keyed socket 230 ofthe actuator 226 (shown in FIG. 45E). The screw driver 320 may beconfigured to engage the keyed socket 148 of the screw 110 (shown inFIG. 16A).

The screw driver 320 includes a proximal end 322 and a distal end 324.The proximal end 322 can have a mating configuration such as a flattenedsurface. The mating surface can engage a knob to facilitate rotation.The mating surface can engage a power source such a drill. The matingconfiguration can be a hand grip. The screw driver 320 can be sized andshaped to fit within the proximal bore of the device 200. The screwdriver 320 can be sized and shaped to fit within the alignment tube 168,268, as described herein.

FIG. 45J shows the distal end 324. The distal end 324 includes a hex tip326. All the flats 328 are sized to fit a female hex of thecorresponding keyed socket 130, 148, 230. In the illustrated embodiment,each flat 328 is 2.5 mm but other sizes are contemplated. The hex tip326 includes a slot 330 across one pair of flats 328. In the illustratedembodiment, the slot 330 bisects the pair of flats 328. In theillustrated embodiment, the slot 330 does not extend beyond the hex tip326. The depth and width of the slot 330 depends on the retaining forcewith the actuator 126, 226 or with the screw 110. The slot can extendabout 0.020″ into the distal end 324.

The hex tip 326 is machined with a lip 332. The hex tip is manufacturessuch that the hex surface is larger than the corresponding socket. Thelip 332 creates an interference between the screw driver 320 and thekeyed socket 130, 148, 230. In the illustrated embodiment, theinterference is on the order of 0.0002″−0.001″ (e.g., 0.0002″, 0003″,0.0004″, 0.0005″, 0.0006″, 0.0007″, 0.0008″, 0.0009″, 0.001″, between0.002″ and 0.005″, etc.). The material of the screw driver 320 isselected maintain the shape of the lip 322. One suitable material isheat treated stainless steel. The configuration of the screw driver 320prevents stripping of the keyed socket 130, 148, 230. In someembodiments (not shown), an elastomer could be inserted into the slot330 to provide additional spring back if needed.

FIGS. 45K-45L show views of the combination tool 238 useful forinserting device 200, actuating gripper 208, approximating the fracturein bone, aligning one or more anchor screw(s) 20, 22, 24, and/orremoving device 200, if desired. The main components of tool 238 are thehub 258, the T-shaped body 240, the device attachment portion 242, andthe alignment tube 268.

The alignment tube 268 is shown in FIG. 45K. The alignment tube 268 canbe coupled to the T-shaped body 240. The combination tool 238 is inplace when the device attachment portion 242 rigidly couples the hub 258and the T-shaped body 240 to the device 200. In this configuration, theremovable alignment tube 268 aligns with the aperture 18 of the device200. In the embodiment depicted in the figures, the T-shaped body 140includes a plurality of apertures including aperture 18′.

In operation, alignment tube 268 is first received in aperture 18′. Inthis position, alignment tube 268 is in axial alignment with aperture 18of device 200. The mating configuration of device 200 and hub 258positions aperture 18 in its desired orientation. With this arrangement,a drill bit, screw driver 270, screw 22 and/or other fastening device ortool may be inserted through the bore of alignment tube 268 such thatthe device(s) are properly aligned with aperture 18. While screw 22 isshown, the alignment tube 268 can be used with screw 20, 24 in the samemanner. The outward end of alignment tube 268 may also serve as a depthguide to stop a drill bit, screw 22 and/or other fastener frompenetrating bone beyond a predetermined depth. Inserting the screw 22through the alignment tube 268 ensures that the screw 22 will have theplacement as shown in FIG. 45M. The alignment tube 268 allows properplacement of the screw 22 even if the aperture 18 or other portions ofthe device 200 are obstructed from the view of the surgeon.

The T-shaped body 240 includes other apertures 10′, 12′, 14′, 16′ thatalign with apertures 10, 12, 14, 16, as described herein. Alignment tube268 may be withdrawn from aperture 18′ as shown, and inserted in anotheraperture 10′, 12′, 14′, 16. The alignment tube 268 can be insertedwithin these apertures to align and insert other screws 20, 22.

The alignment tube 268 is removed in FIG. 45L. The screwdriver 270 isshown coupled to the end of the screw 22. The screwdriver 270 can beused to drive in other screw 20, 24 (not shown). A screw clip 272surrounds a portion of the screwdriver 270 and a portion of the screw22. The screw clip 272 can be used with screw 20, in the same manner asscrew 22. The coupled combination of the screwdriver 270, the screw 22,and the screw clip 272 can be inserted into the alignment tube 268 andmoved toward the fibula. The screwdriver 270 can rotate within the screwclip 272 to drive the screw 22 into the bone.

FIG. 45M shows the screw clip 272 and the screw 22. The screw clip 272can include one or more markings 274. The markings 274 can indicate theproper orientation of the screw 22 into the screw clip 272. The screwclip 272 has a proximal edge 276 which is tapered. The proximal edge 276interacts with the head of the screw 22. As the screw 22 is driven intothe bone, the head of the screw 22 tilts the screw clip 272 away fromthe bone. The screw 22 can be removed from the screw clip 272 throughenlarged slot 278.

FIG. 45N shows the screw clip 272, the screw 22, and the device 200. Thetool 238 ensure proper placement of the screw 22 through the aperture 18in the device 200. FIG. 45O shows the screw clip 272 and the screw 22.As the screw 22 is driven into the bone, the head of the screw 22 tiltsthe screw clip 272 downward as shown by the arrow. The head of the screw22 slides along the proximal edge 276 toward the top surface of thescrew clip 22. As the screw 22 is driven further into the bone, thescrew clip 272 falls away as the screw 22 passes through enlarged slot278.

It is contemplated that the inventive implantable device, tools andmethods may be used in many locations within the body. Where theproximal end of a device in the anatomical context is the end closest tothe body midline and the distal end in the anatomical context is the endfurther from the body midline, for example, on the humerus, at the headof the humerus (located proximal, or nearest the midline of the body) orat the lateral or medial epicondyle (located distal, or furthest awayfrom the midline); on the radius, at the head of the radius (proximal)or the radial styloid process (distal); on the ulna, at the head of theulna (proximal) or the ulnar styloid process (distal); for the femur, atthe greater trochanter (proximal) or the lateral epicondyle or medialepicondyle (distal); for the tibia, at the medial condyle (proximal) orthe medial malleolus (distal); for the fibula, at the neck of the fibula(proximal) or the lateral malleoulus (distal); the ribs; the clavicle;the phalanges; the bones of the metacarpus; the bones of the carpus; thebones of themetatarsus; the bones of the tarsus; the sternum and otherbones, the device may be adapted and configured with adequate internaldimension to accommodate mechanical fixation of the target bone and tofit within the anatomical constraints. As will be appreciated by thoseskilled in the art, access locations other than the ones describedherein may also be suitable depending upon the location and nature ofthe fracture and the repair to be achieved. Additionally, the devicestaught herein are not limited to use on the long bones listed above, butcan also be used in other areas of the body as well, without departingfrom the scope of the invention. It is within the scope of the inventionto adapt the device for use in flat bones as well as long bones.

While various embodiments of the present invention have been shown anddescribed herein, it will be noted by those skilled in the art that suchembodiments are provided by way of example only. Numerous variations,changes, and substitutions may occur to those skilled in the art withoutdeparting from the invention. It should be understood that variousalternatives to the embodiments of the invention described herein may beemployed in practicing the invention. It will be understood that theforegoing is only illustrative of the principles of the invention, andthat various modifications, alterations, and combinations can be made bythose skilled in the art without departing from the scope and spirit ofthe invention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

What is claimed is:
 1. A system comprising: an elongate body comprisingat least a first aperture, a second aperture and a third aperture, theelongate body sized to be inserted within a fibula; a first fastenerconfigured to be inserted through the first aperture in a lateral-medialdirection; a second fastener configured to be inserted through thesecond aperture, the second aperture angled from the first aperture byangle alpha; a third fastener configured to be inserted through thethird aperture, the third aperture angled from the first aperture byangle beta, the third fastener having a longer length than the firstfastener and the second fastener; an actuator configured to actuate aportion of the elongate body to grip an intramedullary canal of thefibula; and a screw clip configured to surround a portion of the firstfastener, the second fastener, or the third fastener.
 2. The system ofclaim 1, wherein angle alpha is between 40 and 80 degrees.
 3. The systemof claim 1, wherein angle beta is between 5 and 45degrees.
 4. The systemof claim 1, wherein the first aperture is oblong, wherein the firstfastener is configured to translate within the first aperture toward theactuator.
 5. The system of claim 1, wherein the portion comprisesbetween one and six members configured to deflect towards theintramedullary canal.
 6. The system of claim 1, wherein the firstfastener and the second fastener are sized to be contained within thefibula.
 7. The system of claim 1, wherein the third fastener is sized toextend into the tibia.
 8. The system of claim 1, wherein the thirdfastener is a screw or suture fixation device.
 9. The system of claim 1,further comprising a tool comprising at least a fourth aperture alignedwith the first aperture, a fifth aperture aligned with the secondaperture and a sixth aperture aligned with the third aperture.
 10. Thesystem of claim 9, wherein the tool is configured to facilitatetranslation of the first fastener within the first aperture to reduce adistance between a first bone segment and a second bone segment.
 11. Thesystem of claim 1, further comprising a reamer comprising a shank and acutting head, the reamer having a smaller shank than the cutting head toincrease flexibility.
 12. A system comprising: an elongate bodycomprising at least a first aperture, a second aperture and a thirdaperture, the elongate body sized to be inserted within a fibula; afirst fastener configured to be inserted through the first aperture in alateral-medial direction; a second fastener configured to be insertedthrough the second aperture, the second aperture angled from the firstaperture by angle alpha; a third fastener configured to be insertedthrough the third aperture, the third aperture angled from the firstaperture by angle beta, the third fastener having a longer length thanthe first fastener and the second fastener; and an actuator configuredto actuate a portion of the elongate body to grip an intramedullarycanal of the fibula; a screw clip configured to surround a portion ofthe first fastener, the second fastener, or the third fastener, whereinthe system is configured such that as a fastener is driven into a bone,the head of the fastener tilts the screw clip away from the bone.
 13. Asystem comprising: an elongate body comprising at least a first apertureand a second aperture, the elongate body sized to be inserted within afibula, the elongate body comprising a distal end and a proximal end; afirst fastener configured to be inserted through the first aperture,wherein the first fastener is configured to be inserted into the firstaperture near the proximal end of the elongate body and wherein thefirst fastener is configured to be translated toward the distal end ofthe elongate body while within the first aperture; a second fastenerconfigured to be inserted through the second aperture, the secondfastener angled from the first fastener by angle alpha when the firstfastener is inserted through the first aperture and the second fasteneris inserted through the second aperture; and a portion of the elongatebody configured to grip an intramedullary canal of the fibula; whereinthe system comprises a third fastener, wherein the third fastener isconfigured for syndesmosis fixation; and a screw clip configured tosurround a portion of the first fastener, the second fastener, or thethird fastener.
 14. The system of claim 13, wherein the third fasteneris angled from the first fastener by angle beta, wherein angle beta isbetween 5 and 45 degrees.
 15. The system of claim 13, wherein anglealpha is between 40 and 80 degrees.
 16. The system of claim 13, furthercomprising an actuator configured to actuate the portion of the elongatebody configured to grip the intramedullary canal.